United States
         Environmental Protection
         Agency
           Prevention, Pesticides
           And Toxic Substances
           (7508W) 	
EPA738-R-96-012
July 1996
&EPA
Reregistration
Eligibility Decision (RED)

Norflurazon

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                  United States,
                  Environmentaf Protection
                  Ager.ay	
Prevention, Pesticides
And Toxic Substances
(7508W)
                                             EPA-738-F-96-012
                                             July 1996
                  R.E.D.   FACTS
                  Norflurazon
     Pesticide
Reregistration
   Use Profile
   Regulatory
       History
     All pesticides' sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered before November 1, 1984, be
reregistered to ensure that they meet today's more stringent standards.
     In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce;
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
     When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 0229, norflurazon.

     Norflurazon is a selective preemergent herbicide used to control
germinating annual grasses arid broadleaf weeds in fruits, vegetables, nuts,
cotton, peanuts, soybeans, and various nonagricultural and industrial areas.
Formulations include granular, flowable concentrate, and water dispersible
granules.
     Norflurazon is applied using aerial application, chemigation (drip
and/or sprinkler), and soil treatment (broadcast and incorporation).
     Use practice limitations prohibit applying norflurazon through any
type of irrigation system (only for the Zorial Rapid 80® product); grazing
livestock in treated areas or cut treated crops for feed; grazing or harvesting
for forage  or hay; and grazing or feeding for forage.

    Norflurazon was first registered as a pesticide in the U.S. in 1974.
EPA issued a Registration Standard for Norflurazon in December 1984 .
(PB86-135159).  A June 1989 Second Round Review draft document was
completed for norflurazon and the studies required in the Second Round
Review document were eventually levied in the August 1990 Data Call-In
(DCI). EPA issued subsequent DCIs in January and June 1993, requiring

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r
             Human Health
               Assessment
additional data on groundwater monitoring and estuarine studies. Currently,
eight norflurazon products are registered.

Toxicity
     In studies using laboratory animals, norflurazon generally has been
shown to be of low acute toxicity.  It is practically nontoxic by the oral and
dermal routes, as well as in terms of eye and dermal irritation in rabbits.  It
has been placed hi Toxicrty Category IV {the lowest of four, categories) for
these effects. Studies on acute inhalation and dermal sensitization are
required.
     A subchronic toxicity study using rats resulted in changes in blood
cell counts, increases in liver and thyroid weights, a decrease in enzyme
activity, and an increase in thyroid effects at the highest dose level. In a
subchronic study using rabbits, increases in enzyme activity, liver weight,
and liver to body weight ratio in both sexes, and a slight redness of the skin
were observed at the highest dose level.
     In a chronic toxicity study using beagle dogs, liver weight increases,
thyroid weight changes, increased cholesterol levels, and a decrease in red
blood cell counts were noted in the high dose groups. A nine-month oral
toxicity study using rats resulted in liver weight increases, an increase in the
incidence of tubular degeneration, and changes in the thyroid weight.
     In a 2-year carcinogenicity study using mice, increases in liver weight
and liver to body weight ratio were observed. Also, increased incidences of
enlarged spleen, nephritis, swollen/enlarged liver, and nodular enlargement
of the liver were observed in male mice at the highest dose level, while
increased incidences of an inflamed kidney (inflammation of kidney and its
pelvis), enlarged liver, and cystic ovaries were observed in female mice at
the highest dose level.
     A chronic toxicity and carcinogenicity study using rats resulted in
increases in liver weight in males and females, kidney weight increases in
both sexes, and thyroid weight increases in males. Also, kidney effects
were observed in the high dose males. Norflurazon was classified as a non-
quantifiable  "Group C" or possible human carcinogen.
     A developmental toxicity study using rats caused skeletal
abnormalities which were not statistically significant and are believed to  be
secondary to maternal effects at the high dose level. In a study using
rabbits, norflurazon caused maternal effects of decreased body weight and
clinical toxicity and developmental toxicity in the form of decreased mean
fetal weight  and skeletal abnormalities.
     A one-generation reproductive toxicity study using mice showed no
treatment-related effects at any dose levels. A 2-generation reproductive
toxicity study in rats caused increased pup death, increased stillborn pups,

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 and increased pup deaths between days 5-14 of lactation at the highest dose
.level. Norflurazon is not considered to be mutagenic.
 Dietary Exposure
      People may be exposed to residues of norflurazdn through the diet.
 Tolerances or maximum residue limits have been established for
 norflurazon in many fruits, vegetables, and nuts, and in cotton, peanuts, and
 soybean commodities (please see 40 CFR § 180.356). EPA has reassessed
 the norflurazon tolerances and found that sufficient data are available to
 support the established tolerances for almonds, apples, apricots, asparagus,
 avocados, blackberries^ blueberries, pherries, citrus, cottonseed, cranberries,
 filberts, grapes, hops, nectarines, peaches, peanuts, pears, pecans, plums,
 raspberries, soybeans, soybean forage and hay, walnuts, milfc, and the fat,
 meat, and meat-by-products of cattle, hogs, horses, and sheep.
      The tolerance for hops, green under 40 CFR §180.356 must be
 revoked and a tolerance for the raw agricultural commodity hops, green and
 dried must be established under tolerances with regional registrations (40
 CFR §180.356(x)). Tolerances for citrus molasses and dried citrus pulp
 must be revoked because citrus molasses is no longer considered a
 significant animal feed item and norflurazon does not concentrate in dried
 citrus pulp. The tolerance for poultry, fat, meat, and meat by-products
 must be revoked. A new tolerance must be established for caneberries.    *
 Existing tolerances for blackberries and raspberries must be revoked once
 the tolerance for caneberries (which encompasses both) is established.
 Additional data are required for cotton gin by-products.  A food additive
 tolerance or Maximum Residue Limit (MRL) must be proposed for citrus
 oil. Several other tolerance revisions have been proposed.
      The Agency is currently reviewing additional residue data required to
 upgrade the existing norflurazon metabolism studies on peanuts, cotton, and
 citrus.  While the submitted storage stability data indicate that residues of
 norflurazon and its  desmethyl metabolite are stable in plant commodities,
 the registrant is required to submit radiovalidation data for the animal
 method. Extended  field trials for field rotational crops must be submitted
 by March 1998.
   ,EPA has assessed the dietary risk posed by norflurazon.  For the overall
 U.S. population and 22 subgroups, exposure from all current norflurazon
 tolerances represents 10% of the Reference Dose (RfD), or amount believed
 not to cause adverse effects if consumed daily over a 70-year lifetime.  The
 exposure level of the most highly exposed subgroup, non-nursing infants
 (<1 year old), represents 47% of the RfD. Therefore, it appears that chronic
 dietary risk is minimal.
      The Agency does not have a concern for acute dietary exposure to
 norflurazon because the margins of exposure (MOE) is 5,000 for females
 of child-bearing age.  An MOE of 100 or greater is considered acceptable.

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Occupational and Residential Exposure
     Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to norflurazon during methods of application
for which no data are currently available (e.g., ring drench use), or for
which there are few data or data of less acceptable quality (e.g., ground
application using granular drop-type spreaders; aerial application of
granulars or liquids;  application of dry flowable formulation using rights-
of-way equipment, backpack sprayer, and low-pressure-handwand sprayer;
and flagger exposure to granulars). The calculations of potential daily
dermal dose of norflurazon received by handlers are used to assess the risk
to those handlers.  It should be noted that relative to dermal exposures, the
estimated inhalation exposures for norflurazon are considered insignificant.
     The MOEs for short and intermediate-term occupational exposure
subchronic systemic effects to norflurazon are greater than 100 for the
exposure scenarios considered. There are no exposure data for the ring-
drench application method. However, current information indicate that
ring-drench handlers would likely receive less exposure than from rights-of-
way handlers using a hose or cannon on a truck.  Since exposures to
handlers for the rights-of-way  use of norflurazon has been calculated to
yield a MOE greater than 100, the Agency expects handler exposure for the
ring-drench use to also exceed 100. However, the Agency will require that
chemical-resistant gloves be worn by ring-drench handlers, due to the lack
of exposure data and the fact that chemical-resistant gloves are required for
the other mixer/loader/applicator scenarios. Therefore, handler exposure
studies are not required for norflurazon at this time.
     The Agency concludes that risks from post-application exposures to
norflurazon would be acceptable, provided entry does not occur
immediately following application. Therefore, post-application exposure
studies are not required at this time for norflurazon.
     The Agency is requiring a Restricted Entry Interval (REI) of 12 hours
set by the Worker Protection Standards (WPS).  If the registrant petitions
for a shorter REI,  chemical specific post-application exposure data would
be required. The Agency is requiring minimum personal protective
equipment (PPE) for pesticide handlers.  In addition, chemical resistant
gloves are required for mixers/loader.s and applicators using handheld
equipment, such as handwands, hoses, or nozzles. Also, the Agency is
requiring the following personal protective equipment for workers who
enter the treated area before the REI has expired: coveralls, chemical
resistant gloves, and shoes plus socks.
Human Risk Assessment
     Norflurazon generally is of low acute toxicity, but causes
developmental and reproductive effects in animal studies and has been
classified as a non-quantifiable Group C, possible human carcinogen. The
registered food crop uses include fruits, vegetables, and nuts. However,

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Environmental
   Assessment
dietary exposure to norflurazon residues in foods is extremely low, as is the
cancer risk posed to the general population.
     There is minimal concern for the risk posed to norflurazon handlers
(mixers/loaders/applicators). Exposure and risk to workers will be
mitigated by the use of PPE required by the WPS, supplemented by early
entry PPE as required by the RED. Postapplication reentry workers will be
required to observe a 12-hour Restricted Entry Interval. This is the
minimum REI required for norflurazon,

Environmental Fate
     The environmental fate of norflurazon is fairly well understood.
Several environmental fate data requirements (batch equilibrium, spray
drift, and.groundwater monitoring studies) remain outstanding.
Norflurazon is a persistent and mobile compound. Norflurazon's primary
route of dissipation appears to be photodegradation in water and on soil to
desmethyl norflurazon with a half-life of 2-3 days and  12-15 days,
respectively. Norflurazon is  stable to hydrolysis and degrades slowly in
aerobic soil with a half-life of 130 days. In an aerobic  aquatic study,
norflurazon degraded to desmethyl norflurazon with a half-life of 6-8
months. Under anaerobic conditions, norflurazon is persistent with a half-
life of approximately 8 months. The degradate, desmethyl norflurazon, is
also persistent under aerobic and anaerobic conditions.
     Norflurazon is mobile to highly mobile in soil. The mobility of  •
desmethyl norflurazon, in soils other than high organic peat, has not been
adequately defined. Because desmethyl norflurazon is a major degradate of
norflurazon and is persistent, a new batch equilibrium study with pure
desmethyl norflurazon is required. Fish accumulation data have shown that
norflurazon has a low potential to bioaccumulate in bluegill siinfish.
     There is a concern that norflurazon may contaminate surface water at
application via spray drift and runoff. Substantial amounts of applied
norflurazon could be available for runoff several months postapplication.
The Agency is not requiring  any surface water monitoring studies at this
time; however, due to the mobility and persistence of norflurazon and
desmethyl norflurazon, a surface water label advisory is required. Due to
the phytotoxic nature of norflurazon and its method of application, spray
drift studies are also required.                                   .
     Norflurazon is not currently regulated under the Safe Drinking Water
Act (SDWA). Therefore no MCL has been established  and water supply
systems are not required to sample and analyze for it. Although, EPA's
Office of Drinking Water has not developed health advisory levels (HALs)
for norflurazon, OPP has determined an estimated HAL of 30 ppb for
comparison with levels potentially found in ground water.
     Norflurazon exhibits some of the properties and characteristics of
chemicals that have been detected in groundwater. Data suggest that

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Risk Mitigation
norflurazon leaches to groundwater as a result of normal agricultural use.
The Agency is concerned about the impact of norflurazon on groundwater
quality. Li addition, norflurazon has been detected in several wells in
Florida at levels that approach or exceed the estimated Health Advisory
Level (HAL) of 30 ppb.  Sandoz, is currently performing groundwater
monitoring studies for the Agency and the state of Florida, to better
evaluate the leaching potential of norflurazon.
Ecological Effects
     Norflurazon is practically nontoxic to avian species on an acute oral
and subacute dietary basis but causes reproductive effects in birds.
Norflurazon is also practically nontoxic to mammals and insects
(honeybees).
     In acute oral toxicity studies, norflurazon is moderately to slightly
toxic to both cold and warm water fish. In a fish early life stage study,
norflurazon caused chronic effects to fish at levels as low as 1.5 ppm. In an
aquatic invertebrate study, norflurazon was slightly toxic. It may cause
chfonic effects on aquatic invertebrate survival and offspring production.
Norflurazon is slightly to moderately toxic to estuarine/marine organisms.
     Norflurazon may cause detrimental effects to certain terrestrial plants.
It is also highly toxic to aquatic plants. The Agency is requiring further
testing to fully assess the toxicity of norflurazon to nontarget aquatic plant
species.    .
Ecological Effects Risk Assessment
      Norflurazon may cause chronic risk to both endangered and
nonendangered avian species for some crops.  It may also cause adverse
effects to small endangered mammals.  Norflurazon poses minimal risk to
honeybees. Regarding aquatic risks, no acute or chronic levels of concern
have been exceeded for freshwater fish, aquatic invertebrates, and
estuarine/marine organisms.                                  •
     Although further data on the toxicity of norflurazon to nontarget
aquatic plants is needed, a plant risk assessment indicates high risk and
endangered plant levels of concern are exceeded for terrestrial, semi-
aquatic, and aquatic plants.
     Levels of concern are exceeded for chronic risk to avian species and
mammalian endangered species. A high risk is posed to endangered
terrestrial, semi-aquatic and aquatic plants. In order to complete the risk
assessment to nontarget aquatic plants, additional data are required for the
following species:  Skeletonemacostatum, Anabaenaflos-aquae, and a
freshwater diatom              ,

   "  The Agency has determined that the current uses of norflurazon
exceed levels of concern for chronic risk to avian species and mammalian
endangered species, and pose a high risk to endangered terrestrial, semi-

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                       aquatic, and aquatic plants. There is a concern that norflurazon may
                       contaminate ground water, as well as surface water.  Norflurazon also
                       poses a potential risk of dermal exposure to pesticide handlers.
                            The registrant has already implemented several risk mitigation
                       measures (such as reduced application rates, use precaution statements, and
                       a ground water label advisory) to decrease the risks posed by norflurazon.
                       The registrant has agreed to further mitigate the chronic risks to birds and
                    ..- mammals by: l).clarifying the current-soil incorporation statements on the
                       product labels, as well as, adding the statement to the use directions for
                       each crop; and 2) clarifying the use directions for banded treatments.  A
                       ground water labeladvisory is being required on aH product labels. This
                       advisory will reduce the potential of norflurazon contaminating ground
                       water. In addition, ground water monitoring studies are being conducted by
                       the registrant to estimate the exposure of norflurazon to me public, as well
                       as, to determine the persistence of residues reaching ground water. These
                       ground water monitoring studies will determine if additional risk mitigation
,                      measures are needed. Likewise, a surface water advisory is being required
                       to decrease the risk of norflurazon contaminating surface water via spray
                       drift and runoff.  Furthermore, the Agency is requiring a spray drift
                       advisory to mitigate the risks to nontarget plants by reducing the potential
                       drift. In addition, spray drift studies are being required to evaluate the
                       exposure and risk to nontarget plants. Finally, in order to decrease the
                       dermal risk to pesticide handlers, the Agency is requiring minimum PPE,
                      which include long-sleeved shirt and long pants, and shoes plus socks. In
                       addition, chemical-resistant gloves are required for mixers/loaders and
                      applicators using hand-held equipment. And .a 12-hour REI is being
                      required to further mitigate the risk to workers and handlers.  These risk
                      mitigation measures, along with the ones already implemented by the
                      registrant, should  reduce the risks of norflurazon to humans and the
                      environment.

 Additional Data       EPA is requiring the following additional generic studies for
         Required  norflurazon to confirm its regulatory assessments and conclusions:
                           Product Chemistry;
                           Acute Inhalation for Technical and 78.6% DF;
                           Dermal Sensitization;
                           Gene Mutation (Ames Salmonella);
                           Directions for Use - Label Amendment to include PHIs;
                           Residue Analytical Methods - Animal (Radiovalidation data);
                           Cropfield Trials - Cotton Gin By-products;
                           Field Rotational Crops (in progress);
                           Tier n Aquatic Plant Growth;
                           Batch Equilibrium Study (Degradate);

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                              Spray Drift;
                              Small Scale Ground Water Monitoring (in progress);
                              The Agency also is requiring product-specific data including product
                         chemistry and acute toxicity studies, revised Confidential Statements of
                         Formula (CSFs), and revised labeling for reregistration.

 Product Labeling        All norflurazon end-use products must comply with EPA's current
           ChangGS    pesticide product labeling requirements and with the following. For a
ReOUired              comprehensive list of labeling requirements, please see the norflurazon
                         RED document.                    t                   •   „    •
                         Worker Protection            -
                              Personal Protective Equipment/Entry Restrictions; Labeling
                              PPE Requirements for Pesticide Handlers
                                   The PPE for handlers is to be based on the acute toxicity of the
                              end-use product.  The minimum PPE requirements for handlers
                              include long-sleeved shirt and long pants, shoes plus socks, and
                              chemical-resistant gloves.
                              Entry Restrictions - Products Intended Primarily for Occupational Use
                              fWPS Uses)
                                   Based on the assessment of human health risks, the Agency
                              does not believe an increase in the REI above what is required in the
                              Worker Protection Standard (WPS) is warranted. The current 12-hour
                              REI, pertaining to each use of the product that is within the scope of
                              the WPS, is to be maintained. The 12-hour REI is the minimum REI
                              for norflurazon.
                              Early Entry PPE: The PPE for early entry are the minimum that
                              would be required under the WPS. These are: coveralls, chemical-
                              resistant gloves, and shoes plus socks.
                         Entry Restrictions - Products Intended Primarily for Occupational Use
                         nsTonWPS Uses)
                                   Some registered uses of norflurazon are outside of the scope of
                              the Worker Protection Standard (WPS).  For nonWPS uses, the
                              Agency is requiring the following:
                              For liquid applications:
                              "Do not enter or allow others to enter the treated area until
                              sprays have dried."
                              For granular applications:
                              "Do not enter or allow others to enter the treated area until dusts
                              have settled. In addition, if the granules are watered-in, do not
                              enter or allow others to enter until the treated area is dry,
                              following the watering-in."

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 Other Labeling Requirements
      Products Intended Primarily for Occupational Use
      The Agency is requiring the following labeling statements to be
 located on all end-use products containing norflurazon that are intended
 primarily for occupational use.
     /                                   •                       -
      Application restrictions
      "Do not apply this product in a way that will contact workers or
      other persons, either directly or through drift. Only protected
      handlers may be in the area during application."

      Engineering controls
      "When handlers use closed systems, enclosed cabs, or aircraft in
      a manner that meets the requirements listed in the Worker
      Protection Standard (WPS) for agricultural pesticides (4Q CFR
      170.240(d)(4-6)), the handler PPE requirements may be reduced
    .  or modified as specified in the WPS."
      User safety requirements
      "Follow manufacturers' instructions for cleaning/maintaining
      PPE. If no such instructions for washables, use detergent and
      hot water. Keep and wash PPE separately from other laundry."
      User safety recommendations
      • "Users should wash hands before eating, drinking, chewing
      gum, using tobacco, or using the toilet."
      • "Users should remove clothing immediately if pesticide gets
      inside.  Then wash thoroughly and put on clean clothing."
      • "Users should remove PPE immediately after handling this product.
     Wash the outside of gloves before removing. As soon as possible,
     wash thoroughly and change into clean clothing."
      Optional soil incorporation statement
      "Exception: if the product is soil-injected, soil-incorporated or
     watered-in, the Worker Protection Standard, under certain
     circumstances, allows workers to enter the treated area if there
     will be no contact with anything that has been treated."
End-Use Labeling
     Soil Incorporation
          The following soil incorporation label statement must be added
     to the specific use directions for each crop on the Solicam DF®
     product lab el:
          "Solicam must be moved into the weed seed germination
          zone to be effective. If no rainfall occurs within 4 weeks

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          after application, the product must be incorporated by
          flood or sprinkler irrigation."
          The following soil incorporation label statement must be added
     to the specific use directions for each crop on the Zorial Rapid 80®
     product label:
          "Zorial Rapid 80 must be applied and incorporated
          by tillage, irrigation or rainfall before weeds
          germinate."
     Banded Treatments
          The following label statement must be added in the
     "Application Equipment" section of the norflurazon Solicam DF®
     and Zorial® product labels to clarify the formulas for the row
     (banded) treatment calculation:
          "The solution should  be mixed to the maximum
          label rate and at no point on the field should the
          solution be applied at a concentration any lower or
          higher than the maximum label rate."
Environmental Hazard Statements
     The following labeling statements must be added to "Environmental
Hazards" section of all norfiurazon end-use product labels:
     Labeling for Wetlands
     "Do not contaminate water when disposing of equipment
     washwaters. Do not apply directly to water, or to areas where
     surface water is present or to intertidal areas below the mean
     high water mark. Do not allow this material to drift onto
     neighboring crops or noncrop areas or use in a manner or at a
     time other than in accordance with label directions because
     animal, plant or crop injury, illegal residues or other undesirable
     results may occur."
     Labeling for Surface Water
     "Norfiurazon can contaminate  surface water through spray drift.
     Under some conditions, norfiurazon may also have a high potential
     for runoff into surface water (primarily via dissolution in runoff
     water), for several months post-application. These include poorly
     draining or wet soils with readily visible slopes toward adjacent
     surface waters, frequently flooded areas, areas over-laying extremely
     shallow ground water, areas with in-field canals or ditches that drain
     to surface water, areas not separated from adjacent surface waters
     with vegetated filter strips, and areas over-laying tile drainage systems
     that drain to surface water."
                       10

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     Labeling for Ground Water
     "This chemical is known to leach through soil into ground water
     under certain conditions as a result of agricultural use. Use of this
     chemical in areas where soils are permeable, particularly wher£ the
     water table is shallow, may result in ground water contamination."
Spray Drift Labeling
     The following language must be placed on each product label that can
be applied aerially:     .
     "Avoiding spray drift at the application site is the responsibility
     of the applicator. The interaction of many equipment-and-
     weather-related factors determine the potential for spray drift.
     The applicator is responsible for considering all these factors
     when making decisions."                                 ,
     "The following  drift management requirements must be followed to
     avoid off-target drift movement from aerial applications to
     agricultural field crops. These requirements do not apply to forestry
     applications, public health uses or to applications using dry
     formulations."
     1 ."The distance of the outer most nozzles on the boom must not
     exceed 3/4 the length of the  wingspan. or rotor."
     2. "Nozzles must always point backward parallel with the air stream
     and never be pointed downwards more than 45 degrees."
   "  "Where states have more stringent regulations, they should be
     observed."
     The applicator should be familiar with and take into account the
information covered in the Aerial  Drift Reduction Advisory Information.
     The following aerial drift reduction advisory information must be
contained in the product labeling:
     [This section is  advisory in nature and does not supersede the
     mandatory label requirements.]
     Information on Droplet Size
     The most effective way to reduce drift potential is to apply large
     droplets. The best drift management strategy is to apply the
     largest droplets  that provide sufficient coverage and control.
     Applying larger droplets reduces drift potential, but will not
     prevent drift if applications are made improperly, or under
     unfavorable environmental conditions (see Wind, Temperature
     and Humidity, and Temperature Inversions).
                       11

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Controlling Droplet Size
•    Volume - Use high flow rate nozzles to apply the highest
     practical spray volume. Nozzles with higher rated flows
     produce larger droplets.
•    Pressure - Do not exceed the nozzle manufacturer's
     recommended pressures. For many nozzle types lower
     pressure produces larger droplets. When higher flow rates
     areraeded, use higher flow rate nozzles instead of
     increasing pressure.
•    Number of Nozzles-Use the minimum number of nozzles
     that provide uniform coverage.
•    Nozzle Orientation - Orienting nozzles so that the spray is
     released parallel to the airstream produces larger droplets
     than other orientations and is the recommended practice.
     Significant deflection from horizontal will reduce droplet
     size and increase drift potential.
•    Nozzle Type - Use a nozzle type that is designed for the
     intended application. With most nozzle types, narrower
     spray angles produce larger droplets. Consider using low-
     drift nozzles. Solid stream nozzles oriented straight back
     produce the largest droplets and the lowest drift.
Boom Length
For some use patterns, reducing the effective boom length to less than
3/4 of the wingspan or rotor length may further reduce drift without
reducing swath width.
Application Height
Applications should not be made at a height greater than 10 feet
above the top of the largest plants unless a greater height is
required for aircraft safety. Making applications at the lowest
height that is safe reduces exposure of droplets to evaporation
and wind.
Swath Adjustment
When applications are made with a crosswind, the swath will be
displaced downward.  Therefore, on the up and downwind
edges of the field, the applicator must compensate for this
displacement by adjusting the path of the aircraft upwind.
 Swath adjustment distance should increase, with increasing drift
potential (higher wind, smaller drops, etc.)
 Wind
Drift potential is lowest between wind speeds of 3-10 mph.
However, many factors, including droplet size and equipment
 type determine drift potential at any given speed. Application
                  12

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 Regulatory
Conclusion
   ,  should be avoided below 3 mph due to variable wind direction
     and high inversion potential. JSTOTE:  Local terrain can
     influence wind patterns. Every applicator should be familiar
     with local wind patterns and how they affect spray drift.
     Temperature and Humidity
     When making applications in low relative humidity, set up
     equipment to produce larger droplets to compensate for
     evaporation. Droplet evaporation is most severe when
     conditions are both hot and dry.
     Temperature Inversions
     Applications should not occur during a temperature inversion
     because drift potential is high.  Temperature inversions restrict
     vertical air mixing, which causes small suspended droplets to
     remain in a concentrated cloud. This cloud can move in
   .  unpredictable directions due to the light variable winds common
     during inversions. Temperature inversions are characterized by
     increasing temperatures with altitude and are common on nights
     with limited cloud cover and light to no wind.  They begin to
     form as the sun sets and often continue into the morning. Their
     presence can be indicated by ground fog; however, if fog .is not
     present, inversions can also be identified by the movement of
     smoke from a ground source or an aircraft smoke generator.
     Smoke that layers arid moves laterally in a concentrated cloud
     (under low wind conditions) indicates an inversion, while
     smoke that moves upward and rapidly dissipates indicates good
     vertical air mixing.
     Sensitive Areas
     The pesticide should only be applied when the potential for drift
     to adjacent sensitive areas (e.g., residential areas, bodies  of
     water, known habitat for threatened or endangered species, non-
     target crops) is minimal (e.g., when wind is blowing away from-
     the sensitive areas).

     Based on the risks assessments in the RED, several risks concerns
were identified.  There is the potential risk of dermal .toxicity to pesticide
handlers. There is also a concern for norflurazon contaminating ground
water and surface water. And the levels of concern are exceeded for
chronic avian species, endangered mammals, and terrestrial, semi-aquatic
and aquatic plants (high risk to endangered species).  Although these risks
exist, the Agency concludes that all uses of products containing
norflurazon, once amended to reflect the risk mitigation measures imposed
in this RED, are eligible for reregistration.
                                       13

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                     Norflurazqn products will be reregistered once the required product-
                specific data, revised Confidential Statements of Formula, and revised
                labeling are received and accepted by EPA.

   For More            EPA1S requesting public comments on the Reregistration
Information  Eligibility Decision (RED) document for norflurazon during a 60-day time
                period, as announced in a Notice of Availability published in the Federal
                Register.  To obtain a copy of the RED document or to submit written
                comments, please contact the Pesticide Docket, Public Response and
                Program Resources Branch, Field Operations Division (7506C), Office of
                Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
                703-305-5805.
                     Electronic copies of the RED and this fact sheet can be downloaded
                from the Pesticide Special Review and Reregistration Information System
                at 703-308-7224. They also are available on the internet on EPA's gopher
                server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
                WWW (World Wide Web) on WWW.EPA.GOV.
                     Printed copies of the RED and fact sheet can be obtained from EPA's
                National  Center for Environmental Publications and Information
                (EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
                " 513-489-8190, fax 513-489-8695.
                     Following the comment period, the norflurazon RED document also
                will be available from the National Technical Information Service (NTIS),
                5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
                     For more information about EPA's pesticide reregistration program,
                the norflurazon RED, or reregistration of individual products containing
                norflurazon, please contact the Special Review and Reregistration Division
                (7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
                     For information about the health effects of pesticides, or for assistance
                in recognizing and managing pesticide poisoning symptoms, please contact
                the National Pesticides Telecommunications Network (NPTN). Call toll-
                free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
                Time, Monday through Friday.
                                       14

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                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                     WASHINGTON, D.C. 20460
                                                                          OFFICE OF
                                                                    PREVENTION, PESTICIDES
                                                                     AND TOXIC SUBSTANCES
                                                                         AUG !  5  !
CERTIFIED MAIL
Dear Registrant:                                       ,,.•'-

      I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case norflurazon which
includes the active ingredient, 4-chloro-5-(methylamino)-2-(a,a,a-trifluoro-/w-tolyl)-3-(lH)-
pyridazinone.  The enclosed Reregistration Eligibility Decision (RED) contains the Agency's
evaluation of the data base of these chemicals, its conclusions of the potential human health
and environmental risks of the current product uses, and its decisions and conditions under
which these uses and products will be eligible for reregistration.  The RED includes the data
and labeling requirements for products for reregistration. It may also include requirements  for,
additional data (generic) on the active ingredients to confirm the risk assessments.

      To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents  which include further instructions. You must follow all instructions and submit
complete and timely responses.  The first set of required responses  is due 90 days from the
receipt of this letter.  The second set of required responses is due  8 months from the date
of this letter.  Complete and timely responses will avoid the Agency taking the enforcement
action of suspension against your products.

      If you have questions on  the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative,
Veronica Dutch at (703) 308-8585.  Address any questions  on required generic data to the
Special Review and Reregistration Division representative,  Karen Jones at (703)  308-8047.

                                                    Sincerely yours,
                                                      MS Rossi, Division Director
                                                     Special Review
                                                      and Reregistration Division
 Enclosures

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              SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
              THE REREGKTRATION ELIGIBILITY DECISION (RED)

 1 -  DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
 reregistration, a DCI letter will be enclosed describing such data.  If product specific data
 are required, a DCI letter will be enclosed listing such requirements.  If both generic and
 product specific data are required, a combined Generic and Product Specific DCI letter will
 be enclosed describing such data. However, if you are an end-use product registrant only and
 have been granted a generic data exemption (GDE) by EPA, you are being sent only the
 product specific response forms (2  forms) with the RED.  Registrants responsible for generic
 data are being sent response forms for both generic and product specific data requirements (4
 forms). You must submit the appropriate response forms (following the instructions
 provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
 may be suspended.

 2.  TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
 will be granted for the 90-day response. Time extension requests may be submitted only with
 respect to actual data submissions.  Requests for time extensions for product specific data
 should be submitted in the 90-day response. Requests for data waivers must be submitted as
 part of the 90-day response. All data waiver and time extension requests must be accompanied
 by a full justification. All waivers and time extensions must be granted by EPA in order to go
 into effect.                                      .                     ,

 3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"--You must
 submit the following items for each product within eight months of the date of this letter
 (RED issuance date).

      a. Application for Reregistration (EPA Form 8570-1). Use only an original
 application form. Mark it "Application for Reregistration." Send your Application for
 Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.

      b. Five copies of draft labeling which complies with the RED and current regulations
 and requirements. Only make labeling changes which are required by the RED and current
 regulations (40 CFR 156.10) and policies.  Submit any other amendments (such as formulation
 changes, or labeling changes not related to reregistration) separately.  You may, but are not
 required to, delete uses which the RED says are ineligible for reregistration.  For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
 on Applying for Registration in the U.S., Second Edition, August  1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
 487-4650).

      c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit  citations of data already submitted and give the EPA
identifier- (MRID) numbers.  Before  citing these studies, you must make sure that they meet
the  Agency's acceptance criteria (attached to the DCI).

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      d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation.  The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e).  A copy of
the CSF is enclosed; follow the instructions on its back.

      e. Certification With Respect to Data Compensation Requirements.  Complete and
sign EPA form 8570-31 for each product.

4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTTCE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.

5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

ByU.S.Mail;

      Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      EPA, 401 M St. S.W.
      Washington, D.C. 20460-0001

By express;

      Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      Room 266A, Crystal Mall 2                                        .
      1921 Jefferson Davis Hwy.
      Arlington, VA 22202

        'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections.  EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.

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REREGISTRATION ELIGIBILITY DECISION
             NORFLURAZON
                  LIST A
                CASE 0229
          ENVIRONMENTAL PROTECTION AGENCY
            OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

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                         TABLE OF CONTENTS
NORFLURAZON REREGISTRATION ELIGIBILITY DECISION TEAM ;		i

EXECUTIVE SUMMARY ...;............	 .,-;		 . .. ..  v

I.     INTRODUCTION  ...		  	..;............!

II.    CASE OVERVIEW	-. •..". '.   		'>.                2
      A.    Chemical Overview	 1	2
      B.    Use Profile			     2
      C.    Estimated Usage of Pesticide		.	; 4
      D.    Data Requirements',	5
      E.    Regulatory History	..'...'	        6

in.   SCIENCE ASSESSMENT.......'.	;........................ 6
      A.    Physical Chemistry Assessment.	  ............... 6
            1.    Identification of Active Ingredient	6
      B.    Human Health Assessment.	7
            1.    Hazard and Dose Response Assessment	 7
                 a.    Acute Toxicity	*........	7
                 b.    Subchronic Toxicity	8
                 c.    Chronic Toxicity and Carcinogenicity.	.. 9
                 d.    Developmental and Reproductive Toxicity	 12
                 e.    Mutagenicity	 7...... 14
                 f.    Metabolism	15
                 g.    Toxic Endpoints of Concern Identified for Use in Risk
                       Assessment	 ...... 15
            2.    Exposure Assessment .	 .... . .. ... . 16
                 a.    Dietary Exposure	 .	 16
                 b.    Occupational and Residential. . ;	.......;...... 23
            3.    Risk Assessment	..;.....	 28
                 a.    Dietary		..'..•	'. ... '. ....... 28
                 b.    Occupational and Residential.	 29
      C.    Environmental Assessment		..31
            1.    Ecological Toxicity Data		......... 31
                 a.    Toxicity to Terrestrial Animals	 ..."	 31
                 b.    Toxicity to Aquatic Animals .,	 .  . . ..... 33
                 c.    Toxicity to Plants		 37
            2.    Environmental Fate		 .39
                 a.    Environmental Fate Assessment.	 39
                 b.,    Environmental Fate and Transport. . ..-.";	  ..... 42

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                  c.    Water Resources	46
            3.     Exposure and Risk Characterization.	49
                  a.    Ecological Exposure and Risk Characterization	49
                  b.    Water Resources Risk Implication for Human Health .. .68

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	 69
      A.    Determination of Eligibility	'.		 69
      B.    Determination of Eligibility Decision	 . 70
            1.     Eligibility Decision.	 70
            2.     Eligible and Ineligible Uses	. .	•'.	70
      C.    Regulatory Position		 		;... 70
            1.     Tolerance Reassessment	.....:...	70
            2.     Summary of Risk Management Decisions.	 74
                  a.    Human Health	74
                  b.    Environmental	76
            3.     Spray Drift Advisory	81
            4.     Labeling Rationale	81

V.    ACTIONS REQUIRED OF REGISTRANTS	  		86
      A.    Manufacturing-Use Products	86
            1.     Additional Generic Data Requirements	86
            2.     Labeling Requirements for Manufacturing-Use Products	87
      B.    End-Use Products			:	   87
            1.     Additional Product-Specific Data Requirements. 	87
            2.     Labeling Requirements for End-Use Products	88
                  a.    Worker Protection			88
                       (1)   Personal Protective Equipment/Entry Restrictions;
                             Labeling	88
                       (2)   Other Labeling Requirements	 . 90
                  b.    End-Use Labeling Requirements	92
                  c.    Environmental Hazard Statements	92
                  d.    Spray Drift Labeling	 93
      C.    Existing Stocks	96

VI.   APPENDICES	 99
      APPENDIX  A.    Table of Use Patterns Subject to Reregistration.	 101
      APPENDIX  B.    Table of the Generic Data Requirements and Studies Used to
                       Make the Reregistration Decision	,	112
      APPENDIX  C.    Citations Considered to be Part of the Data Base Supporting
                       the Reregistration of Norflurazon	125
      APPENDIX  D.    Combined Generic and Product Specific Data Call-In .. 143
            Attachment 1.     Chemical Status Sheets	163
            Attachment 2.     Combined Generic and Product Specific Data Call-in
                              Response Forms (Form A inserts) Plus
                              Instructions	165

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      Attachment  3.
      Attachment  4.
      Attachment  5.
      Attachment  6.
APPENDIX  E.
      Generic and Product Specific Requirement Status and
      Registrant's Response Forms (Form B inserts) and
      Instructions	 169
      EPA Batching of End-Use Products for Meeting Data
      Requirements for Reregistration	;... .176
      List of AH Registrants Sent This Data Call-In (insert)
      Notice ...... .„•	178
      Cost Share, Data Compensation Forms, Confidential
      Statement of Formula Form and Instructions.... 179
List of Available Related Documents.....	........ 187

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 NORFLURAZON REREGISTRATION ELIGIBILITY DECISION TEAM

 Office of Pesticide Programs:

 Biological and Economic Analysis Division
Harry Gaede
James Saulmon
Margaret Cogdell  ',  '

Environmental Fate and Effects Division

Mary Frankenberry
Sharlene Marten
Renee Costello
Nicholas Mastrota
Dana Spatz

Health Effects Division

Kathy Martin
Timothy McMahon
Carol Lang
David Miller

Registration Division

Eugene Wilson
Jonanne Miller
Tina Levirie
Economic Analysis Branch
Biological Analysis Branch
LUIS
 Science Analysis and Coordination Staff .
 Science Analysis and Coordination Staff
 Environmental Risk Characterization Branch
 Environmental Risk Characterization Branch
 Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Toxicology Branch H
Occupational and Residential Exposure Branch
Reregistration Support Chemistry Branch
Fungicide-Herbicide Branch
Fungicide-Herbicide Branch
Registration Support Branch
Special Review and Reregistration Division
Karen Jones
Linda Propst
Reregistration Branch
Reregistration Branch

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 ADI
 AE
 a.i.
 ARC
 CAS
 CI
 CNS
 CSF
 DFR
 ORES
 DWEL
 EEC

 EP
 EPA
 FDA
 FIFRA
 FFDCA
 FOB
 GLC
 GM
 GRAS
 HA

 HOT
 LC
   50
LD,
LDlo
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L .
MOE
MP
MPI
MRID

N/A
NOEC
 GLOSSARY OF  TERMS AND ABBREVIATIONS

    Acceptable Daily Intake. A now defunct term for reference dose (RfD).
    Acid Equivalent                                                 ,
   •Active Ingredient
    Anticipated Residue Contribution
    Chemical Abstracts Service
    Cation
    Central Nervous System
    Confidential Statement of Formula
   Dislodgeable Foliar Residue
   Dietary Risk Evaluation System
   Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.
   drinking water) lifetime exposure at which adverse, non carcinogenic health effects are not
   anticipated to occur.                 ^
   Estimated Environmental Concentration. The estimated pesticide concentration in an
   .environment, such as a terrestrial ecosystem.        '
   End-Use Product                                                          •
   U.S. Environmental Protection Agency       ,
   Food and Drug Administration
   Federal Insecticide, Fungicide, and Rodenticide Act
   Federal Food, Drug, and Cosmetic Act
   Functional Observation Battery
   Gas Liquid Chromatography
   Geometric Mean
   Generally Recognized as Safe as Designated by FDA                               .
   Health Advisory (HA). The HA values are used as informal guidance to municipalities and
   other organizations when emergency spills or contamination situations occur.
   Highest Dose Tested
   Median Lethal Concentration. A statistically derived concentration of a substance that can be
   expected to cause death in 50% of test animals.  It is usually .expressed as the weight of
   substance per weight or volume of water, air or feed, e.g., mg/L, mg/kg or ppm.
   Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
   50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It
   is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
   Lethal Dose-low. Lowest Dose at which lethality occurs.
 .  Lowest Effect Level                                    -
   Level of Concern
   Limit of Detection                                         •
   Lowest Observed Effect Level
   Maximum Acceptable Toxicant Concentration                "    ,
   Maximum Contaminant Level Goal (MCLG)  The MCLG is used by the Agency to regulate
   contaminants in drinking water under the Safe Drinking Water Act.
   Micrograms Per Gram
   Milligrams Per Liter
   Margin of Exposure                 ,
   Manufacturing-Use Product
   Maximum Permissible Intake
'   Master Record Identification (number). EPA's system of recording and tracking studies
   submitted.                                      ,                    :
   Not Applicable                                                                 '
   No effect concentration
                                                111

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            GLOSSARY OF TERMS AND ABBREVIATIONS

NPDES        National Pollutant Discharge Elimination System
NOEL         No Observed Effect Level
NOAEL        No Observed Adverse Effect Level
OP            Organophosphate
OPP           Office of Pesticide Programs                                      ,
PADI          Provisional Acceptable Daily Intake
PAG           Pesticide Assessment Guideline
PAM          Pesticide Analytical Method
PHED         Pesticide Handler's Exposure Data
PHI           Preharvest Interval                     ,
ppb            Parts Per Billion
PPE           Personal Protective Equipment              •                      .
ppm           Parts Per Million
PRN           Pesticide Registration Notice
Q"j            The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer. Risk Model
RBC           Red Blood Cell      •
RED           Reregistration Eligibility Decision
REI           Restricted Entry Interval
RfD           Reference Dose
RS            Registration Standard
SLN           Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC            Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD            Toxic Dose. The dose at which a substance produces a toxic effect
TEP           Typical End-Use Product
TGAI          Technical Grade Active Ingredient
TLC           Thin Layer Chromatography
TMRC         Theoretical Maximum Residue Contribution
torr           A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO     Food and Agriculture Organization/World Health Organization
WP           Wettable Powder
WPS          Worker Protection Standard
                                               IV

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 EXECUTIVE SUMMARY

       EPA has completed its reregistration eligibility decision regarding the pesticide
 norflurazon, 4-chloro-5-(methylamino)-2-(a,a,a^trifluoro-m-tolyl)-3-(2Jff)-pyridazinone. This
 decision includes a comprehensive reassessment of the required target data base supporting
 the use patterns of currently registered products. Norflurazon is a selective preemergent
 herbicide used to control germinating annual grasses and broadleaf weeds in fruits,
 vegetables, nuts, cotton, peanuts, soybeans, and various nonagricultural and industrial areas.
 The Agency has concluded that all products registered for all uses, once amended to reflect
 the risk mitigation measures imposed in this RED, are eligible for reregistration.

       To mitigate potential risks of dermal exposure to pesticide handlers, the Agency is
 requiring use of Personal Protective Equipment and a Restricted Entry Interval of 12 hours for
 norflurazon.  The Agency has determined that norflurazon exceeds levels of concern for
 chronic effects to birds and mammals, and for nontarget plant species. Risk mitigation
 measures including reduced application rates and use precaution statements have been added
 to the product labels. The registrant has agreed to implement the following risk mitigation
 measures to further reduce the chronic risk to birds  and mammals: 1) clarify the current soil
 incorporation statements on product labels; and 2) clarify use directions for banded
 treatments. The Agency is also requiring a surface  water label advisory, a ground water label
 advisory, and a spray drift advisory in order to further reduce the risks of norflurazon to
 humans and the environment. Additional data on product chemistry, acute toxicity, gene
 mutation, residue chemistry, plant protection, batch equilibrium, spray drift, and ground water
 monitoring are required to confirm EPA's risk assessment and conclusions.

       Before reregistering the products containing norflurazon, the Agency is requiring that
 product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include
product chemistry for each registration and acute toxicity testing.  After reviewing these data
 and any revised labels and finding them acceptable  in accordance with Section 3(c)(5) of
FIFRA, the Agency will reregister a product.  Those products which contain other active
ingredients will be eligible for reregistration only when the other active ingredients are
determined to be eligible for reregistration.

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I.
INTRODUCTION
       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data t© fulfill the requirements,.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.

       FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregistration involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.

       This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of norfiurazon. The document consists of six sections. Section I is the
introduction.  Section n describes norfiurazon, its uses, data requirements  and regulatory
history. Section El discusses the human health and environmental assessment based on the
data available to the Agency. Section IV presents the reregistration  decision for norfiurazon.
Section V discusses the reregistration requirements for norfiurazon. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.

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H.    CASE OVERVIEW

      A.    Chemical Overview                      .

            The following active ingredient(s) are covered by this Reregistration Eligibility
      Decision:
            Common Name:
Norflurazon
            Chemical Name:
            Chemical Family:
4-chloro-5-(memylamino)-2-(a,a,a-trifluoro-#z-
toly l)-3 -(2H)-py ridazinone

Fluorinated pyridazinone
            CAS Registry Number:   27314-13-2
            OPP Chemical Code:     105801
            Empirical Formula:
            Trade and Other Names:  Zonal®, Solicam®, and Evital®
      •     Basic Manufacturer:      Sandoz Agro, Inc.

      B.     Use Profile

            The following is information on the currently registered uses with an overview
      of use sites and application methods. A detailed table of these uses of norflurazon is in
      Appendix A.

            For Norflurazon:
            Type of Pesticide: Herbicide
            Mode of Action:
Selective herbicide; suppresses the production of
carotenoids through uptake of pesticide in the root
system.

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 Use Sites:                                                         .

 TERRESTRIAL FOOD CROP:
 Small Fruit (blackberry, blueberry, caneberries, cranberry, raspberry (black,
 red); Pome Fruit (pear); Stone Fruit (apricot, cherry, nectarine, peach, plum,
 prune); Miscellaneous Vegetable (asparagus); Subtropical Fruit (avocado);
 Tree Nut (filbert (hazelhut), pecan, walnut (English/black)).

 TERRESTRIAL FOOD+FEED CROP:
 Small Fruit (grapes); Citrus Fruit; Pome Fruit (apple); Tree Nut (almond);
 Flavoring/Spice Crop (hops); Fiber/Oil Crop (cotton); Legume/Oil Crop
 (peanuts, soybeans).

 TERRESTRIAL NON-FOOD CROP:
 Agricultural uncultivated areas; Industrial areas (outdoor); Nonagricultural
 rights-of-way/fencerows/hedgerows; Nonagricultural uncultivated areas/soils.

 Target Pests: Broadleaf weeds, grasses and sedges.

 Formulation Types Registered:

 Type:        Technical grade, End use

 Form:       Crystalline (97.8%), Dry flowable (78.6%), Flowable
             concentrate (52.7 to  80.0%), and Granular (5.0%)

 Methods of Application:

 Types of Treatment:
 Aerial application, chemigation (drip and/or sprinkler), soil treatment
 (broadcast and incorporation), spray.

 Equipment:
 Aircraft, conventional hydraulic sprayers, drip and sprinkler irrigation
 equipment.

 Timing'       '              • ,  .
Applied in early spring as a preplant or preemergence treatment, or applied in
the fall after the plant/tree has gone dormant.

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c.
Maximum Rates of Application:

Terrestrial Food Crop
Apricot, Asparagus, Avocado, Blackberry, Blueberry, Cherry, Filbert
(hazelnut), Nectarine, Peach, Pear, Pecan, Plum, Prune, Raspberry (black, red),
and Walnut (English/black)--Coarse soil-2 Ib/A, Medium soil-3 Ib/A, Fine soil-
41b/A;

Cranberry~8 Ib/A.                     .

Terrestrial Food+Feed Crop
Almond—Coarse soil-1 Ib/A, Medium soil-3 Ib/A, Fine soil-4 Ib/A; Apple,
Grape-Coarse soil-2 Ib/A, Medium soil-3 Ib/A, Fine soil-4 Ib/A;

Citrus fruits-8 Ib/A;

Hops-Coarse soil-2.5  Ib/A, Medium soil-3.75 Ib/A, Fine soil-5 Ib/A;

Cotton-Coarse soil-1 Ib/A, Medium soil-1.5 Ib/A, Fine Soil-2 Ib/A; Peanuts,
Soybeans—2 Ib/A.             •     .

Terrestrial Non-food Crop
Industrial areas (outdoor), Nonagricultural rights-of-
way/fencerows/hedgerows, Nonagricultural uncultivated areas/soils—4 Ib/A.

Use Practices Limitations for Zorial® 80 for Use on Cotton, Peanuts, and
Soybeans:

Do not graze livestock in treated areas or cut treated crops for feed.  Do not
graze or harvest for forage or hay. Do not graze or feed for forage.
                                                                       V
Do not apply through any type of irrigation  system.
                                                         ^
Estimated Usage of Pesticide
      This section summarizes the best estimates available for the pesticide uses of
norflurazon. These estimates are derived from a variety of published and proprietary
sources available to the Agency. The data, reported on an aggregate and site (crop)
basis, reflect annual fluctuations in use patterns as well as the variability in using data
from various information sources.

      The table below summarizes the pesticides use by site.

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                 AVERAGE ANNUAL USAGE OF NORFLURAZON ON CROPS
                                RECENT YEARS (1991-1994}
sans?- -
i - v^ ',.*^',, ,, ^
Almonds
Apples
Cotton •
Cranberries
Grapefruit
Grapes
Nectarines
Oranges
Peaches
Pecans
Plums
Soybeans
Other Crops'
TOTAL
AGUES
$a8H#*'-
390,000
332,300
10,115,000
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E.     Regulatory History

       Norflurazon was registered in the United States in 1974 as a selective
preemergent herbicide used to control germinating annual grasses and broadleaf weeds
in certain crop and noncrop areas. A Registration Standard was issued in December
1984.  Additional data were required in Data Call-ins issued in August 1990, January
1993 and June 1993.  This Reregistration Eligibility Decision document reflects a
reassessment of all data which were submitted in response to the Registration Standard
and the subsequent DCIs.

SCIENCE ASSESSMENT

A.     Physical Chemistry Assessment

       The product chemistry data base is adequate to support reregistration of all
pesticide products containing norflurazon as an active ingredient.

       1.    Identification of Active Ingredient

             Norflurazon [4-chloro-5 -(methylamino)-2-(a, a,a-trifluoro-7M-tolyl)-3 -
       (2#)-pyridazinone] is a selective herbicide used to control grasses and
       broadleaf weeds.                                                   '
                          Figure A
                                           Cl
                    Empirical Formula:
                    Molecular Weight:
                    CAS Registry No.:
                    OPP Chemical Code:
C12H9CIF3N30
303.7
27314-13-2
105801
             Norflurazon is a an odorless white crystalline solid with a melting point
       of 177°C.  Norflurazon is noncorrosive and is stable under alkaline and acid
       conditions, but is sensitive to light. Norflurazon is only slightly soluble in
       water (<40 ppm) and is moderately soluble in acetone (5 g/100 mL) and
       ethanol(14.2 g/100 mL).

             A search of the Reference Files System (REFS) conducted 3/16/95
       identified a single norflurazon manufacturing-use product (MP) registered to

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              Sandoz Agro, Inc. under Shaughnessy No. 105801, the 97.8% technical
              (T; EPA Reg. No. 55947-55).  Only the Sandoz 97.8% T is subject to a
              reregistration eligibility decision.

                     The Norflurazon Guidance Document dated 12/13/84 and the 1989
              Second Round Review (SRR) required additional product chemistry data for
              the only registered manufacturing-use product, the Sandoz 97.8% T. Data
              submitted in response to the Guidance Document were reviewed in the SRR,
              and additional data are required fpr the Sandoz technical concerning
              GLNs 62-1, 63-17, and 63-20.  Nitrosamine analyses were also required under
              62-1. Although the Agency has received data from the registrant indicating that
              nitrosamine levels in the 97% T product are at less than detectable levels (i.e.,
              <0.1 ppm), the Agency has some concerns with the quality of this data as a
              result of an EPA audit of the performing laboratory. The Agency earlier
              requested that additional freshly-produced batches of the 97% T be analyzed
              for nitrosamines, but these data have not yet been submitted by the registrant.
              Therefore, the Agency cannot at this time make a final judgement as to whether
              nitrosamine levels would cause dietary exposure concerns. Additional data on
              nitrosamine analyses for the 97% T are required.

       B.     Human Health Assessment

              1.     Hazard and Dose Response Assessment

                    The toxicological data base on norflurazon is adequate to support
              reregistration eligibility.

                    a.     Acute Toxicity

 Table I. Acute Toxicity Testing Using the Norflurazon Technical
; •• % % V. S ? SSSS f f " •
: 	 '.f.:..'". 	 'm$$- ""<- \
Oral LDjo-rat
81-1 MRID 00111612
Dermal LD^— rabbit*
81-2 MRID 00090786
81-3 Inhalation LQo-rat
Eye Irritation—rabbit
81-4 MRID.00111612
Dermal Irritation— rabbit
81-5 MRID 00111612
Dermal Sensitization— guinea pig**
81-6 MRID 00111615
;' ' JfcESHLfS- ' *
9.3g/kg(M)
>20,000mg/kg
acceptable study unavailable
non-irritating up to 7 days post-instillation of test material
non-irritating up to 7 days post- application of test material
acceptable study unavailable
•. -^ s -.
, CJ&mZQ'M '
rv
rv /
,.
- IV
rv
-
  The punty of the test material was not reported in this study.
 ** Norflurazon technical at a concentration of 0.1% produced no evidence of sensftization in male guinea pigs. However, the purity of the test
material used in this study was not reported, and the positive control assay failed to demonstrate the sensitivity of the sensftization procedure used
in this study.                                                                      '

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b.     Subchronic Toxicity

       Li a subchronic oral toxicity study, rats of the C.F.E. strain
(20/sex) received SAN-9789 (Norflurazon) in the diet for 90 days at
doses of 0, 250, 500, or 2500 parts per million (ppm) (0,12.5, 25, or
125 mg/kg/day). There were no significant effects of norflurazon on
survival, body weight, body weight gain or food consumption in male
and female rats at any dose level.  At the 2500 ppm dose level, the
following  effects were observed at 13 weeks: an increase in red cell
count of 19% in male rats; a decrease in alkaline phosphatase activity of
38% and 42% in male and female rats, respectively; a decrease in
aspartate aminotransferase activity of 36% in female rats; an increase in
liver weight of 14% and 12% in male and female rats, respectively; an
increase in thyroid weight of 96% in male rats; and an increase in the
incidence  of hypertrophic acinar epithelium and colloid depletion of the
thyroid in  male rats. At the 500 ppm dose level after 13 weeks of
treatment, thyroid weight was increased by 20% in male rats with an
increased incidence of hypertrophic acinar epithelium and colloid
depletion.  Li addition, red cell count was increased by 14% in male rats,
aspartate aminotranferase was decreased by 10% in female rats, and
liver weight was increased by 14% in male rats. The  systemic No
Observed Effect Level (NOEL) was considered to be 12.5 mg/kg/day in
male rats,  and 25 mg/kg/day in female rats. The systemic lowest effect
level (LEL) was considered to be 25 mg/kg/day in male rats based on an
increased red cell count, increased thyroid and liver weight, and
increased incidence of hypertrophic acinar epithelium and colloid
deposition in the thyroid. The systemic LEL was considered to be 125
mg/kg/day in female rats, based on an increased liver weight and liver
to body weight ratio. The decreased alkaline phosphatase and aspartate
aminotranferase activity observed in females at this dose were of
unknown biological significance. This study was classified as core
supplementary data, based on the lack of dose level verification as well
as verification of doses received in the diet (guideline §82-1; MRHD
00091055). Although this guideline is not satisfied, acceptable chronic
toxicity data are available; therefore, the information to upgrade this
study to acceptable is requested, but is not required.

       A twenty-one day dermal toxicity study was conducted with
norflurazon 80% wettable powder (WP). Li this study, male and female
New Zealand white rabbits (3 males and 3 females) received repeated
dermal application of norflurazon 80% WP at doses of 150 mg 80% *
WP/mL (approximately 375 mg/kg/day) and 400 mg 80% WP/mL
(approximately  1000 mg/kg/day), 5 days per week, 6-8 hours per day,

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 for 21 days. The systemic NOEL is 375 mg/kg/day for males and
 females, and me systemic LEL is 1000 mg/kg/day for males and
 females, based on increases in alkaline phosphatase activity, liver
 weight, and liver to body weight ratio in both sexes. The dermal NOEL
 is 375 mg/kg/day for both sexes, and the dermal LEL is 1000 mg/kg/day
 for both sexes, based on slight erythema observed immediately after
 bandage removal (guideline §82-2; MRID 00063617).

 c.     Chronic Toxicity and Carcinogenicity

       In a 6-month toxicity study, norflurazon technical was
 administered in the diet to male and female beagle dogs (4/sex/group) at
 dose levels of 0, 50, 150, or 450 ppm (0, 1.53, 5.02, and 14.27 mg/kg
 for males; 0, 1.58, 4.77, and 17.75 mg/kg for females).  At the 150 ppm
 dose level, liver weight was increased by 38% in male dogs and by 23%
 in female dogs.  Thyroid weight was increased by 33% in male dogs and
 37% in female dogs at this dose level. Also noted at the 150 ppm dose
 level were increases in cholesterol in both sexes (23-40% in males,
 6-34% in females), a decrease in SGPT (36-38% in males, 13-20% in
 females) and SGOT (4-23% in males, 13-23% in females). At the 450
 ppm dose level, similar changes were observed in male and female
 dogs, with the additional observation of a decrease in red cell count in
 female dogs (79-92% of control). The systemic NOEL was determined
 to be 50 ppm (1.53 mg/kg/day [males]; 1.58 mg/kg/day  [female's]). The
 systemic LEL was determined to be 150 ppm (5.02 mg/kg/day [males];
 4.77 mg/kg/day [females]), based on increased absolute and relative
 liver weight and increased cholesterol in both sexes (guideline §83-1;
MRID 00111618).

      A nine-month oral toxicity study (MRID 00091056) was
 conducted using the F0 generation of rats from a two-year
 carcinogenicity study (MRID 00082019). In this study, rats were given
technical norflurazon in the diet at dose levels of 0, 125, 250, or 500
ppm (0, 6.25, 12.5, and 25 mg/kg/day) for 39 weeks. There were no
 significant effects of norflurazon on survival, body weight, body weight
gain, food consumption, food efficiency, hematology, or clinical
chemistry in male or female rats at any dose level tested. At 500 ppm,
liver weight was increased by 14% and 23% in male and female rats
respectively, at 39 weeks.  Kidney weight was not significantly affected,
but the incidence of hyaline pigment deposition (many tubules) in male
rats and hyaline pigment deposition (few tubules) in female rats was
increased,  as Was the incidence of medullary congestion in high dose
female rats. The incidence of tubular degeneration was increased in both

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sexes at the 500 ppm dose level. Thyroid weight was decreased in males
by approximately 30% vs control, while thyroid weight was increased in
females between 11-47% vs control. Gonadal weight (left gqnad) was
increased in female rats by 30%. At 250 ppm, thyroid weight was
decreased by 30% in male rats, but was increased by 11-29% in female
rats. However, there were no reported microscopic alterations in this
organ at any dose level tested. Gonadal weight in female rats was
increased by 17% vs. control. The systemic NOEL was determined to
be 250 ppm (12.5 mg/kg/day) in both sexes. The systemic LEL was
determined to be 500 ppm (25 mg/kg/day) in both sexes, based on the
dose-related increase in liver weight in male and female rats at 39
weeks, the increase in gonad weight of females, and the microscopic
changes observed in kidneys of both sexes. Although dramatic effects
on thyroid weight were observed at 250 ppm in both sexes, there were
no data indicating any alteration in histology of this organ. Thus, the
weight change, while indicative of an effect of norflurazon, is not
supported as a toxic effect based on available data (guideline:
non-guideline study; classified as core supplementary; MKED
00091056).

       A two-year carcinogenicity study was conducted in male and
female CD-I HaM/ICR Swiss mice in which 125 mice/sex/dose were
administered technical norflurazon in the diet at dose levels of 0, 85,
340, or 1360 ppm (0, 12.8, 58.7, or 218.8 mg/kg/day) for 100-104
weeks. No significant effects were observed on body weight, body
weight gain, clinical toxicity, or food consumption at any dose level
tested. Liver weight was increased by 9% and 15% in male and female
mice at the 340 ppm dose level, and by 27% and 21% at the 1360 ppm
dose level, respectively. The liver to body weight ratio was increased by
19% and 4% in male and female mice at the 340 ppm dose level, and by
43% and 19% at the 1360 ppm dose level, respectively.  Increased
incidences of enlarged spleen, nephritis, swollen/enlarged liver, and
nodular enlargement of the liver were observed in high dose male mice,
while increased incidences of pyelonephritis, enlarged liver, and cystic
ovaries were observed in high dose female mice. Carcinogenic potential
was evidenced by an increased incidence of hepatic adenoma and
combined adenoma/carcinoma in high dose male mice.  The systemic
NOEL was determined to be 12.8 mg/kg/day (85 ppm) for male mice,
and 58.7 mg/kg/day (340 ppm) for female mice. The systemic LEL was
determined to be 58.7 mg/kg/day (340 ppm) for male mice, based on the
increased incidence of enlarged spleen, increased absolute and relative
liver weight, and increased incidence of nephritis. The systemic LEL
was determined to be 218.8 mg/kg/day (1360 ppm) for female mice,
                     10

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 based on the increased incidence of enlarged liver and cystic ovaries,
 the increased absolute and relative liver weight, and the increased
 incidence of pyelonephritis (guideline §83-2; MRID 00111649).

       A chronic toxicity and carcinogenicity study was conducted in
 Sprague-Dawley rats. In this study, technical norflurazon was
 administered in the diet at dose levels of 0, 125, 375, or 1025 ppm   (6,
 6.25, 18.75, or 51.25 mg/kg/day) for 104 weeks. No significant effects '
 of norflurazon were evident for survival, body weight, body weight
 gain, or food consumption in male or female rats at any dose level
 tested^ At 375 ppm, liver weight was increased by 17% and 13% in
 male and female rats at 52 weeks and by 24% and 27% at 1025 ppm at
 52 weeks for both sexes. At 104 weeks, liver weight was increased by
 12-14% in male and female rats, and kidney weight by 16-39% vs
 controls. The weight of the thyroid was also increased at the 1025 ppm
 dose in male rats at  104 weeks. An increased incidence of
 hydronephrosis was observed in high dose male rats at 52 weeks vs
 control, while the incidence of nephritis was increased in male rats
 (terminal sacrifice + dying on test) at the 1025 ppm dose. The incidence
 of tubular casts was increased in female rats at the high dose in those
 rats surviving to.study termination. Other microscopic alterations
 observed at the high dose included an increased incidence of
 parathyroid hyperplasia (both sexes), hemdsiderin pigment deposition in
 the spleen (males only) and liver (both sexes), and endometritis and
 squamous metaplasia of the uterus (females).

       The systemic NOEL was determined to be 375 ppm (18.75
 mg/kg/day) for both sexes. The systemic LEL was determined to be
 1025 ppm (51.25 mg/kg/day) in both sexes, based on the increased
 kidney weight and accompanying microscopic pathologic changes, as
well as the increase in liver weight in male and female rats and the
increase in thyroid weight in males. There was no evidence of
 carcinogenicity for norflurazon (guideline 83-5; MRIDs 00111617 and
 00082019).

      As a result of the July 18, 1990 meeting of the OPP/Health
Effects Division Carcinogenicity Peer Review Committee, norflurazon
was classified as a non quantifiable Group C - possible human
carcinogen - based upon statistically significant pair-wise comparisons
of the incidence of liver adenomas and combined liver adenomas/
carcinomas as well as statistically positive trends for these lesions in
male CD-I mice receiving 218.8 mg/kg/day norflurazon technical in the
diet for up to 104 weeks (MRID 00111649).
                     11

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 d.     Developmental and Reproductive Toxicity

       In a developmental toxicity (teratology) study, rats of the
 Sprague-Dawley strain received either 0, 100", 200, or 400 mg/kg/day
 norflurazon technical by oral gavage on gestation days 6 through 15
 inclusive. The maternal toxicity NOEL was determined to be < 100
 mg/kg/day, and the maternal toxicity LEL was determined to be < 100
 mg/kg/day, based on reductions in body weight gain for the period of
 dosing and for the dosing plus post-dosing period. The developmental
 toxicity NOEL was determined to be > 400 mg/kg/day, and the
 developmental toxicity LEL was determined to be > 400 mg/kg/day.
 Developmental toxicity was suggested at the 400 mg/kg/day dose level
 in the form of an increase in bipartite thoracic vertebrae (10th-13th) and
 an increase in rudimentary 14th ribs. However, these increases were not
 statistically significant and are believed to be secondary to maternal
 effects at the high dose (guideline 83-3; MRTD 00063621).

       A developmental toxicity study was conducted in New Zealand
 White rabbits, which received either 0, 10, 30, or 60 mg/kg/day
 norflurazon technical by oral gavage on gestation days 7 through 19
 inclusive. The maternal toxicity NOEL was determined to be 30
 mg/kg/day, and the maternal toxicity LEL was determined to be 60
 mg/kg/day, based on decreased body weight gain and clinical toxicity
 (abortion) at this dose level. The developmental toxicity NOEL was
 determined to be 30 mg/kg/day, and the developmental toxicity LEL
 was determined to be 60 mg/kg/day, based on statistically significant
 increases in the fetal incidence of incompletely ossified frontal bones,
 16 caudal vertebrae, unossified first metacarpal, unossified middle
 phalanx of the fifth digit of the forelimb, and unossified proximal
 epiphysis of the tibia at the 60 mg/kg/day dose level. A 12% decrease in
 mean fetal weight was also observed at the 60 mg/kg/day dose level
 (guideline 83-3; MRID 00131151 and 00131152).

       A one-generation reproduction study was conducted in male and
 female CD-I (HaM/ICR Swiss) mice. In this study, norflurazon
 technical was administered in the diet at nominal doses of 0, 85, 170,
, or 340 ppm (0, 12.1, 24.3, or 48.5 mg/kg/day). There were no
 treatment-related effects reported in parental mice or in offspring at any
 of the dose levels tested. The  systemic and reproductive NOEL were
 determined to be £ 48.5 mg/kg/day, and the systemic and reproductive
 LEL were determined to be > 48.5 mg/kg/day. This study was classified
 as core supplementary data (guideline 83-3; MRID 00080751).
                       12

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       A three-generation reproductive toxicity study was conducted in
male and female Sprague-Dawley rats. In this study, norflurazon
technical (98.8% a.i.) was administered in the diet at nominal doses of
0,125, 375, or 1025 ppm (0, 6.25, 18.75, or 51.25 mg/kg/day). TheF0
generation of rats received norflurazon technical at nominal dose levels
of 0, 125, 250, or 500 ppm (0, 6.25, 12.5, or 25.0 mg/kg/day) for 18
weeks prior to mating to produce the Fla and Flb generation. Subsequent
to this, the Fla generation was used for a two year feeding study, while
the Flb generation received norflurazon technical at 0,125, 375, or 1025
ppm for  13 weeks and were then mated to produce the F^ and F2b
generations. The F^ litter continued to receive test article and were
sacrificed just prior to delivery of a second litter (F3b), which was
examined for developmental effects. There were no data presented for
parental rats in this study. Reproductive data presented indicated no
apparent effects of norflurazon treatment on reproductive performance
at any  dose level tested. The systemic toxicity NOEL was determined to
be 18.75 mg/kg/day, and the systemic toxicity LEL was determined to
be 51.25 mg/kg/day. The reproductive toxicity NOEL was determined
to be £ 51.25 mg/kg/day and the reproductive toxicity LEL was
determined to be > 51.25 mg/kg/day. Due to the lack of parental toxicity
data in this study, the systemic toxicity NOEL and LEL were based on
the results of subchronic and chronic testing with norflurazon, in which
an effect level of 25 mg/kg/day was indicated. However, the Health
Effects Division RfD/Quality Assurance Committee determined that it
was not appropriate to extrapolate a systemic NOEL/LEL to this study
based on effects observed from subchronic and chronic toxicity studies.
Nonetheless, the Committee felt that the conclusions  drawn from the
subchronic and chronic toxicity studies could^be used to justify that the
dose levels were probably adequate: Therefore, the systemic toxicity
NOEL and LEL were considered appropriate (guideline 83-4; MRID
00080750).

       A 2-generation reproductive toxicity study was conducted in
male and female Wistar rats. In this study, norflurazon technical was
administered in the diet at dose levels  of 0, 150, 750, or 1500 ppm over
2 generations (0, 10.2, 50.8, or 102.5 mg/kg/day for F0 males; 0, 12.1,
62.0, or 129.7 mg/kg/day for F0 females; 0,  13.2, 67.8, or 138.6
mg/kg/day for F! males; 17.1, 81.7, and 173.0 mg/kg/day forFl
females). The NOEL for systemic toxicity was determined  to be 150  -
ppm (10.2 mg/kg/day for males and 12.1 mg/kg/day for females), and '
the systemic toxicity LEL was determined to be 750 ppm (50.8
mg/kg/day for males and 62.0 mg/kg/day for females), based on
significant increases in liver and kidney weights observed in both
                      13

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generations of parental rats and the increased incidence of
hepatocellular hypertrophy in both generations of parental rats. The
reproductive toxicity NOEL was determined to be 750 ppm (50.8
mg/kg/day for males and 62.0 mg/kg/day for females), and the
reproductive toxicity LEL was determined to be 1500 ppm (102.5
mg/kg/day for males and 129.7 mg/kg/day for females), based on an
increase in pup deaths, an increase in stillborn pups in the Flb and f^
litters, and a decreased lactation index in the F2b litter (guideline 83-4;
MRID 435223-01).

      The studies examining developmental and reproductive toxicity
of norflurazon were considered by the Health Effects Division RfD/Peer
Review Committee in a meeting held March 16,1995. Overall, the
committee concluded that treatment with norflurazon was associated
with reproductive toxicity in the form of increased pup death, increased
stillborn pups, and increased pup deaths between days 5-14 of lactation
at a dose of 1500 ppm. Developmental toxicity was not evident in
treated rats, but developmental toxicity in rabbits was evident at a dose
of 60 mg/kg/day in the form of decreased mean fetal weight, slight
delays in ossification of the skull and limbs, and an increase in the
incidence of 13th ribs. These developmental effects occurred at a dose
that was maternally toxic.
e.
Mutagenicity
       In a mutagenicity study, norflurazon technical was tested for the
ability to cause mutations in Salmonella typhimurium strains TA-1535,
1537, 1538, 98, and 100 and in Saccharomyces cerevisiae strain D4 in
the absence and presence of metabolic activation (Aroclor 1254 induced
rat liver S-9). Norflurazon technical at concentrations of 0, 0.1, 1.0, 10,
100, or 500 ^ig/plate (non-activation) and concentrations of 0, 0.1, 1.0,
10.0, 100 or 500 jug/plate (activation) [1000 //g/plate for TA1537 in a  .
second assay]  showed no evidence of mutagenicity in this study.  There
was no evidence of cytotoxicity in any of the strains at any of the dose
concentrations used. Positive controls appeared adequate for all strains
except TA100, where positive controls in the absence and presence of
S-9 gave less than 2 times the number of revertants observed in negative
controls. In the absence of data demonstrating toxic effects, the highest
concentration used in this study is inadequate and higher concentrations
should have been assayed (guideline 84-2; MRID 00072974). In an in
vitro chromosomal aberration assay, norflurazon did not cause a
clastogenic response at doses of 63-500 £4g/ml  in the«absence of liver
S-9 and at doses of 125-1000 //g/ml in the presence of S-9 (guideline
                      14

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 84-2; MRID 00155734). In an in vitro unscheduled DNA synthesis
 assay (UDS), norflurazon at doses ranging from 1-333 Mg/ml failed to
 induce unscheduled DNA synthesis in primary rat hepatpcytes
 (guideline 84-2; MRID 00155375).

 f.     Metabolism

       Norflurazon was administered as single oral doses of 2 or 110
 mg/kg, a single i.v. dose of 2 mg/kg, or a single oral dose of 2 mg/kg
 following administration of 2 ppm in animal diet for 14 days to separate
 groups of rats. In urine, between 18.5-28.4% of the administered dose
 was eliminated by  96 hours post-dose, and between 65.3-79.5% of the
 administered dose was eliminated in feces. Thirteen metabolites of
 norflurazon were isolated. There appear to be 4 pathways for
 norflurazon metabolism: N-demethylation; displacement of the chlorine
 atom by glutathione; glutathione attack on the aromatic ring; and
 replacement of the chlorine atom by hydrogen (guideline 85-1; MRID
 00260490). An additional metabolism study was conducted to
 determine the presence of the sulfone metabolite in rat excreta after a
 single low oral dose of 1 mg/kg, or a single high oral dose of 100
 mg/kg. The sulfone metabolite was detected in both urine and feces of
 dosed rats. In urine, the sulfone metabolite accounted for 0.03% of
 urinary radioactivity at the low dose, and 0.2% of urinary radioactivity
 at the high dose. The sulfone metabolite accounted for 0.3% of fecal
 radioactivity at the low dose, and for 0.1% of fecal radioactivity at the
 high dose (guideline 85-1; MRID 430815-01).

 g.    Toxic Endpoints of Concern Identified for Use in Risk
      Assessment.

      The Health Effects Division's (HED) Less than Lifetime
 Committee selected the following toxicology endpoints for use in risk
 assessment for norflurazon  (Toxicology Endpoint Selection Document,
4/21/95):                     .

      The endpoint selected for the acute dietary risk
      assessment is a NOEL of 30 mg/kg/day. This is
      the developmental NOEL based on increased
      skeletal variations observed at the dose of 60
      mg/kg/day in a rabbit developmental toxicity
      study.
                     15

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2.
      The Reference Dose (RfD) for norflurazon was
      established at 0.015 mg/kg/day  based upon a
      chronic toxicity (6 month) study in dogs with a
      NOEL of 1.58 mg/kg/day (RfD/Peer Review
      Report of Norflurazon, March 1.6, 1995).  An
      uncertainty factor of 100 was applied to account
      for the interspecies extrapolation and intraspecies
      variability. Norflurazon has not been reviewed by
      the FAO/WHO Joint Committee on Pesticides
      Residues (JMPR), and therefore an Acceptable
      Daily Intake (ADI) has not been established.

      A Qi* has not been established for norflurazon.
      The Reference Dose (RfD) approach was selected
      for the quantification of potential human cancer
      risk.

      Dermal absorption of norflurazon is estimated to
      be 0.1%, based on a rat dermal absorption study
      (MRTD 00086808). It should be noted that dermal
      absorption estimates were not used/required since
      a systemic NOEL from  a dermal exposure toxicity
      study was selected as the appropriate endpoint for
      occupational/residential risk assessment.

      The endpoint selected for both the short and
      intermediate-term occupational/residential
      exposure assessment is  a NOEL of 375
      mg/kg/day. This is the systemic NOEL from a
      21-day dermal toxicity study in rabbits where
      increased alkaline phosphatase activity and
      increased absolute and relative liver weights were
      observed at the dose level of 1000 mg/kg/day.

Exposure Assessment

a.    Dietary Exposure

      Regulatory Background

      The Residue Chemistry Chapter of the Registration Standard was
dated 7/6/84. Norflurazon was also the subject ofa. Residue Chemistry
Chapter of the Second Round Review (SRR) Registration Standard
                            16

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 dated 5/10/89, These documents summarized regulatory conclusions of
 available residue chemistry data and specified that additional data were
 required for reregistration purposes. Several submissions of data have
 been received since the 1989 SRR. The information contained in this
 document outlines the current Residue Chemistry Science Assessments
 with respect to the reregistration of norflurazon.

       Tolerances for residues of norflurazon in/on various raw
 agricultural commodities and processed food/feed commodities are
 currently expressed as the combined residues of norflurazon (4-chloro-
 5-(methylamino)-2-(a,a,a-trifluoro-m-tolyl)-3-(2J?)-pyridazinone) and
 its desmethyl metabolite, 4-chloro-5-(amino)-2-(a,a,a-trifiuoro-w-
 tolyl)-3-(2#)-pyridazinone [Source: 40 CFR §180.356 (a), §185.4550,
 and §186.4450]. Rotational crop tolerances have been established for
 the indirect combined residues of norflurazon and its desmethyl
 metabolite in/on peanuts and peanut hay, hulls, and vines resulting from
 the primary application of norflurazon to cotton [Soufce'40 CFR
 §180.356 (b)].
                      *-,'--      •         '        "          •
 Directions for Use

       Use directions for norflurazon (EPA Reg No. 55497-78) allow
 multiple applications during the growing  season to the soil  around
 avocado trees, blueberries, citrus trees, grape vines, nut trees, pome fruit
 trees, and stone fruit trees but do not specify preharvest intervals (PHIs)
 for these crops. The label for the 78.6% DF (EPA Reg. No. 55497-78)
 must be amended to include PHIs for the  above fruit crops.

 Plant Metabolism

       For purposes of risk assessment, the qualitative nature of the
 residue in plants is adequately understood, and consists of norflurazon
 and its desmethyl norflurazon metabolite. However, for purposes  of
 reregistration, additional confirmatory information are required in order
 to upgrade the existing [phenyl-14C]norflurazon metabolism studies on
 peanuts,, cotton, and citrus. Results from the adequate [pyridazinyl-
 14C]norflurazon plant metabolism study support the registrant's proposed
metabolic pathway involving formation of desmethyl norflurazon with
 subsequent conjugation via the primary amine.

    -  The residues of concern in plants are norflurazon and desmethyl
norflurazon, pending submission of confirmatory [phenyl-14C]
                      17

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       norflurazon metabolism studies; the chemical structures of these
       metabolites are presented in Figure B.
Figure B. Chemical names and structures of norflurazon and its metabolite in plants.
          O
    Norflurazon
                               Desmet
                                                      O
hyl Norflurazon
             Plant metabolism studies reviewed in the norflurazon Residue
       Chemistry Chapter (7/84) indicated that norflurazon is translocated to
       the foliage, ears, and grain of corn, the roots of carrots, the foliage and
       nuts of peanuts, the foliage, heads, and grain of wheat, and the seeds
       and foliage of cotton.  Plant metabolism studies reviewed in the 1989
       SRR, although judged inadequate, also indicated that norflurazon is
       absorbed from the soil by citrus, soybean, and cotton. Conjugated and
       free forms of norflurazon and its desmethyl metabolite were identified
       in these plants at maturity.  Since the 1989 SRR was issued, peanut,
       cotton, and citrus [pyridazinyl and phenyl-14C]norflurazon metabolism
       studies have been submitted.   Additional information on
       radiovalidation, liquid scintillation counts (LSC) and related data, and
       high performance liquid chromatograms (HPLC) are currently being
       reviewed by the Agency.

       Animal Metabolism                                      .

             For purposes of risk assessment, the qualitative nature of the
       residue in ruminants and poultry is adequately understood and consists
       of parent norflurazon and its desmethyl norflurazon metabolite.

       Residue Analytical Methods - Plants and Animals  -

             Methods are available for tolerance enforcement and data
       collection. Methods I and n listed in the Pesticide Analytical Method
       (PAM) Vol. n are available for tolerance enforcement for the
       determination of norflurazon and its desmethyl metabolite in/on
       cottonseed and cranberries. However, the Agency believes  that these
                             18

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 methods may not adequately recover bound residues since they do not
 involve an initial alkaline hydrolysis step. Pending submission of data
 from the [14C-phenyl]norflurazon metabolism study which confirms that
 norflurazon and desmethyl norflurazon residues are the only residues to
 be included in the tolerance expression, the Agency will recommend
 that the PAM Vol H methods be replaced with Sandoz Method AM-
 0820-1292-3 which has undergone EPA Beltsville radiovalidation (by
 means of Method AM-0820-0592-2), and deemed an adequate
 enforcement method for determination of these two residues in plants.

       Method AM-0875-1092-1, a GC/ECD analytical method for the
 determination of norflurazon and desmethyl norflurazon in beef liver,
 kidney, muscle, and fat commodities, has also undergone a successful
 independent laboratory validation and an EPA Beltsville TMV: the
 method (subsequently revised and renamed AM-0875-1092-2) is
 suitable for enforcement purposes and will partially meet EPA's GDLN
 171-4(d) requirements after incorporation of pertinent HED comments.
 The registrant is still required to submit a method and fortification
 recovery results for milk (but the Agency will not require either
 independent laboratory validation or a Beltsville TMV if the present
 method for beef liver,  kidney, muscle, and fat is simply updated or
 modified slightly to incorporate analysis of a milk commodity).

       The registrant is still required to submit radiovalidation data for
 the animal (AM-0875-1092-1) method.

       The FDA PESTDATA database dated 1/94 (Pam Vol. I,
 Appendix II) indicates that norflurazon and desmethyl norflurazon are
 not recovered using PAM, Vol. I Multiresidue Protocol E Sections 303
 or 304 and recoveries using Protocol D are variable.

 Storage Stability
                • .    •               .          •     \
       The requirements for storage stability data are satisfied for the
 purposes of reregistration and support the previously submitted RAC
residue studies.  Residues of norflurazon and desmethyl norflurazon are
 stable in frozen storage for at least 12 months in apples and milk and at
least 39 months on the following commodities: alfalfa forage and hay,
almonds, apples, asparagus, cottonseeds, cranberries, grapes, oranges,
peaches, peanut forage, peanut hay, peanut hulls, peanut nutmeats,
raisins, soybean forage, soybean grain, soybean hay,  and walnuts. In
addition, these data adequately support the recently submitted grape
processing study. However, additional storage stability data were
                      19

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required to support the storage intervals for processed fractions of citrus
(12 months), cottonseed (5 months), and soybeans (6 months). These
data were submitted in 12/95 and are currently being reviewed by the
Agency.

Magnitude of the Residue in Meat Milk. Poultry, and Eggs

       There are established tolerances for residues of norflurazon and
desmethyl norflurazon in milk and meat, fat, and meat by-products of
poultry, cattle, hog, horses, goat, and sheep.  Tolerances for residues of
norflurazon in eggs have not been established.

       The norflurazon Guidance Document (12/84) concluded that
acceptable data were available to support the established tolerances on
meat, milk, and poultry. The HED Metabolism Committee determined
that the residues  of concern in ruminant commodities are norflurazon
and its desmethyl metabolite.

       Since total radioactive residues were 0.462 ppm, 0.021 ppm, and
0.101 ppm in poultry liver, fat, and eggs, respectively, following an ca.
lOOx dosage of [14C-phenyl]-norflurazon to laying hens, the Agency
concluded that there is no reasonable expectation of finite residues (40
CFR  180.6(a)(3)) and will not require the submission of a poultry
feeding study; the tolerances on poultry commodities should therefore
be revoked.

Magnitude of the Residue in Plants

       The reregistration requirements for the magnitude of norflurazon
residues in plants are fulfilled for almonds, apples, apricots, asparagus,
avocados, blackberries, blueberries, cherries, citrus, cottonseed,
cranberries, filberts, grapes, hops, nectarines, peaches, peanuts, pears,
pecans, plums, raspberries, soybeans, soybean forage and hay, and
walnuts. Adequate field trial data depicting residues of norflurazon and
its desmethyl metabolite following applications made according to the
maximum registered use patterns have been submitted for these
commodities.  Geographical representation is adequate and a sufficient
number of trials reflecting representative formulation classes were
conducted. Additional data are required on cotton gin by-products. No
data are available for cotton-gin byproducts (formerly called  cotton gin
trash). Based  on the revised Table n Residue Chemistry, September
1995, data are required on residues of norflurazon in/on cotton-gin
byproducts harvested at normal maturity from plants treated at the
                      20

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maximum seasonal application rate (2 Ib ai/A/season).  The cotton must
be harvested by commercial equipment (or a simulation thereof) to
provide an adequate representation of plant residue from the ginning
process.  The data should reflect three cropfield trials on stripped cotton
and three picked cotton and represent the major U.S. cotton growing
regions.                     ,

Magnitude of the Residue in Processed Food/Feed

       The reregistration requirements for the magnitude of the
norflurazon residue in processed food/feed commodities are fulfilled for
apples, grapes,' hops, and plums. The registrant has  submitted
supplemental storage stability data for citrus, cottonseed, and soybean
processed fractions which are currently being reviewed by the Agency.
A summary of the available data and reregistration status for each
commodity is presented below.

Apple: The norflurazon Guidance Document (12/84) required apple
processing data. The Agency subsequently waived this data
requirement because no detectable residues were found in/on apples
treated at up to 3x the maximum registered use rate.

Citrus: Acceptable residue data are available for purposes of the risk
assessment. However, for purposes of reregistration, acceptable data
depicting the frozen storage stability of norflurazon and its desmethyl
metabolite in citrus processed commodities for ca. 12 months are
required.

The data indicated that the combined residues of norflurazon and
desmethyl norflurazon concentrated 5.9x in citrus oil following two
preemergence soil applications of the 80% DF formulation at an
exaggerated rate of 5x. Provided that storage stability issues are
adequately resolved, the  data indicate that a 701 Maximum Residue
Limit (MRL) for the combined residues of norflurazon and desmethyl
norflurazon in/on citrus oil at 0.7 ppm is required. Citrus molasses is no
longer considered a significant feed item (Table n, September 1995),
and no tolerances are therefore necessary.

Cottonseed: Acceptable residue data are available for purposes of the
risk assessment. However, for purposes o.f reregistration, acceptable
data depicting the frozen storage stability of norflurazon and its
desmethyl metabolite in cottonseed processed commodities for ca. 5
months are required.  Residues of norflurazon and its desmethyl
                      21

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metabolite were not detected in cottonseed samples that had been
treated with a single'preemergence soil application of the 80% DF
formulation at an exaggerated rate of up to 5x nor were any residues
detected in any fraction processed from treated cottonseed (i.e., seeds,
hulls, meal, oil, and soapstock) (detection limit of 0.02 ppm). Provided
that storage stability issues are adequately resolved, the data indicate
that no food/feed additive tolerances are required for cottonseed
processed commodities.

Grape: Acceptable residue data are available for grape processed
commodities. The combined residues of norflurazon and its desmethyl
metabolite in two samples each of raisins, wet pomace, dry pomace, or
juice processed from grapes bearing detectable residues following
treatment with a  single preemergence soil application of the 80% DF
formulation at an exaggerated rate of up to 5x were measured at <0.02
ppm.  Combined residues in raisin waste were 0.265-0.320 ppm.
However, raisin waste (wet pomace and dry pomace) are no longer
considered significant feed items. These data indicate that food/feed
additive tolerances are not needed for any processed grape commodity.

Plum: Data from a plum processing study (fresh prunes) indicated that
no measurable weathered residues occur in plums (fresh prunes) treated
at up to 3x the maximum registered use rate. Although the 3x
application rate is less than OPP/HED's maximum theoretical
concentration factor for plums/prunes, the processing study data
available from grapes processed into raisins (considered similar to
processing plums into fresh prunes) indicate that no concentration in
fresh prunes is likely. No food/feed additive tolerances are required.

Soybean:  Acceptable residue data are available for purposes of the risk
assessment. However, for purposes of reregistration, acceptable data  .
depicting the frozen storage stability of norflurazon and its desmethyl
metabolite in soybean processed commodities are required.

       The combined residues of norflurazon  and its desmethyl
metabolite in two samples each (one from each test) were as follows:
soybean hulls, O.045 and <0.06 ppm; meal, 0.065 and <0.104 ppm;
crude and refined oil, <0.04 ppm; and soapstock, <0.04 and <0.052
ppm.  The commodities were processed from soybeans treated with a
single preemergence soil application of the 80% DF formulation at 2 or
6 Ib ai/A (Ix and 3x). The Agency  concluded that because the 3x
treatment rate reportedly affected the growth of the soybeans, the 3x
data should not be used to determine if concentration occurs. Therefore,
                      22

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           .      .        •    • v        •-'.-.
 provided that storage stability issues are adequately resolved, the
 available data indicate that combined residues of norflurazon arid its
 desmethyl metabolite  do not concentrate in soybean hulls-meal, crude
 oil, refined oil, or soapstock and that food/feed additive tolerances are
 not required. Also, the Agency has concluded that residue data on the
 aspirated grain fraction is not required due to the early season use of
 norflurazon.

 Confined Rotational Crops

       The nature of the residue in rotational crops is adequately
 understood. Norflurazon and its.desmethyl metabolite are the residues
 of concern.  Sandoz submitted a confined rotational crop study that was
 reviewed by the Agency. After the submission of additional
 information to the Agency, the study was deemed adequate. The
 Agency concluded that the data requirement for confined rotational
 crops was satisfied, and that a limited field trial in rotational crops study
 was required.         '

 Field Rotational Crops

       Limited field trial data were submitted depicting residues of
 norflurazon and desmethyl norflurazon in rotational crops planted
 following a single application of the 80% DF to cotton. The data from
 the limited field trial indicated that there are detectable residues in
 rotated crops after a 12-month rotational interval. The Agency required
 extended field trials for root and tuber vegetables, leafy vegetables, and
 cereal grains to support a 12-month rotational interval and
 recommended that a study protocol be submitted for review prior to
 commencing the studies. A study protocol was reviewed by the Agency
 and found acceptable providing the registrant follows the Agency's    :
 comments and recommendations.  In April 1995, the registrant initiated
the extended field trials.  The final report is due in March 1998.

 b.     Occupational and Residential

       All products containing norflurazon are intended primarily for
occupational use. At this time no products containing norflurazon are
intended for homeowner use. None of the  registered occupational uses
are likely to involve applications at residential sites.

    •   The Agency has determined that there is a potential exposure to
mixers, loaders, applicators, or other handlers during registered use-
patterns associated with norflurazon.  Specifically, the Agency is
                     23

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concerned about potential exposures to handlers during the mixing,
loading, flagging, and applying of norflurazon for groundboom, drop-
type spreader, ring-drench, rights-of-way, backpack, low-pressure
handwand, chemigation, and aerial applications.

Handler (Mixer/Loader and Applicator) Exposure

       Generic data from the Pesticide Handler Exposure Database
(PHED) version 1.1 were used to determine the potential exposure
values for the specified uses of norflurazon.

       Based on the use patterns and potential exposures described
above, eight major exposure scenarios were identified for norflurazon:
a) mixing/loading the granular formulation for drop-type spreader and
aerial applications; b) mixing/loading the dry flowable formulation for
groundboom and aerial applications; c) mixing/loading the dry flowable
formulation for chemigation application; d) applying the granular
formulation with a drop type spreader and with aerial equipment;
e) applying the dry flowable formulation with groundboom and aerial
equipment; f) applying the dry flowable formulation with the rights-of-
way equipment; g) flagging for aerial application of the granular
formulation; h) flagging for aerial application of the dry flowable
formulation; i) mixing, loading, and applying the dry flowable
formulation for low-pressure handwand application; j) mixing, loading,
and applying the dry flowable formulation for backpack application;
and k) mixing, loading, and applying the dry flowable formulation for
ring-drench application.

       The potential daily dermal dose is calculated using the following
formula:
Potential Daily Dermal Dose
                      •• Daily Dermal Exposure I JHi-\ • I
                                ^    (Day)  (
                                                  Body Weight (Kg))
       These calculations of potential daily dermal dose of norflurazon
received by handlers are used to assess the risk to those handlers. It
should be noted that relative to dermal exposures, the estimated
inhalatipn exposures for norflurazon are considered insignificant.

       The potential exposure estimates for the .above mentioned
exposure scenarios are presented in Table IH.  Table IV summarizes the
quality of this exposure data.
                      24

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Post-Application Exposure

      There are no data available to address post application exposure for
persons reentering areas treated with norflurazon. Based on the use patterns,
post-application exposures are expected, particularly following applications in
nurseries.

3.    Risk Assessment

      a.     Dietary

             Tolerances for norflurazon residues in/on agricultural and animal
      commodities are published in 40 CFR §180.356, in processed food in
      §185.4450, and in feed in §186.4450. The available data support the
      established tolerances on all commodities except hops, citrus oil, and
      poultry. Changes in the tolerance for citrus oil were not reflected in the
      DRES analysis since citrus oil is not a DRES commodity; the Agency
      concluded that poultry commodities are a 40 CFR 180.6(a)(3) situation
      and the tolerances on poultry commodities should therefore be revoked;
      Thus, for the purposes of this analysis, only the tolerance for hops was
      reassessed from 3 ppm to 2 ppm. As hops are now considered a RAC in
      both the fresh (green) and dried forms, the 1.0 ppm tolerance for hops,
      green and the 3 ppm tolerance for hops, dried (§185.4550) should be
      revoked, and a regional 2 ppm tolerance for hops (green and dried)
       should be established in §180.356(x).

             Tolerance level residues and 100 percent crop treated
       assumptions were made for all.commodities. No anticipated residue
       (AR) information was used in this analysis.

      Acute Dietary Risk

             The Agency does not have a concern for the acute dietary
       margin of exposure (MOE) for norflurazon. This is demonstrated by the
       MOE of 5,000 for females of child-bearing age when considering both
       the established and the proposed tolerances in the exposure assessment.

       Chronic Dietary Risk

             The chronic analysis  for norflurazon is a worst case estimate of
       dietary exposure with all residues at tolerance level and 100 percent of
       the commodities assumed to be treated with norflurazon. Based on the
                            28

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 exposure estimates in this analysis, chronic dietary risk from the uses of
 norflurazon being considered for reregistration is not of concern.

       A DRES chronic exposure analysis was performed to estimate
 the Theoretical Maximum Residue Contribution (TMRC) for the general
 population and 22 subgroups.  This analysis results in a TMRC which is .
 10% of the RfD for the U. S. general population. For the highest
 subgroup, non-nursing infants (<1 year old), this subgroup's TMRC is
 47% of the RfD.

 b.     Occupational and Residential

 Risk from Occupational Exposures

       Risk (MOE) is calculated as follows:

       MQE = NOEL /Potential Daily Dermal Dose.
  ''
       The NOEL for norflurazon is 375 mg/kg/day. It is a systemic
 NOEL from a 21-day dermal study.
       MOEs, using occupational exposures as described in Table HI,
were estimated for handlers, and are presented in Table V.

       The MOEs for short and intermediate-term occupational
exposure subchronic systemic effects are greater than 100 for the
exposure scenarios considered. .There are no exposure data for the ring-
drench application method. However, with the current information the
Agency has about the ring drench method of application, ring-drench
handlers would likely receive less exposure than from rights-of-way
handlers using a hose or cannon on a truck.  Since exposure to handlers
for the rights-of-way use of norflurazon has been calculated to yield a
margin of exposure greater than 100, the Agency expects the handler
exposureTor the ring drench method of application would also exceed
100. However, the Agency will impose a chemical-resistant glove
requirement for ring-drench handlers, due to the lack of exposure data
and the fact that chemical-resistant gloves are required for both the other
mixer/loader/applicator scenarios.
time.
      Handler exposure studies are not required for norflurazon at this
                     29

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                      Risk from Post-Application Exposure
Table V.
               There are no data available to address post application exposure
       for persons reentering areas treated with norflurazon.  However, the
       Agency notes that: (1) the toxicological endpoint is based on relatively
       minor systemic effects, (2) the effects were observed at the.dose-level of
       1000 mg/kg/day, and (3) the MOEs for all handlers (using the NOEL of
       375) were greater than 100  without the use of additional PPE, other than
       chemical-resistant gloves. These considerations have led the Agency to
       conclude that the risks from post-application exposures to norflurazon
       would be acceptable, provided entry does not occur immediately
       following application. Therefore, post-application exposure data are not
       required at this time.

Occupational Risks Associated with Uses of Norflurazon.

' ^'ifcppwtw 'Scettt&fif > ' ",*'<,'''%"" ""' ' ' *;, *'" ' '•
,+. * *' MMiMiim ivi mtfimimi^T^?!! ytft\\\f }i ^^ f &,' f m , ,^ t^i:v j
'"'-"'' tmK&w&ny)^'''' ^A
Mixer/Loader
Mixing/loading granular* for drop type spreader
Mixing/! oading granulars for aerial application
Mixing/loading dry flowables for groundboom application
Mixing/loading dry flowables for aerial application
Mixing/loading dry flowables for chemigation
Applicator
Rights-of-Wav Sprayer
Granular drop type spreader
Groundboom (dry flowable)
Aerial (granular)
Aerial Giiuid spray)
Flaeser
Flagging (granular)
Flagging (Ho,uid spray)
0.055
0.55
0.63
1.6
1.6

0.69
0.091
0.09
0.18
1.1

0.27
0.23
^rjgjfjr;

6800
680
600
240
240

543
4100
4200
2050
330

1400
1700
Mixer/Loader/Applicator
Low Pressure ETandwand (Field Grown Nursery)
Backpack Sprayer (Field Grown Nursery)
Ring Drench (dry flowable)
0.28 (gloves)
0.17 (gloves)
No data
1339
2,206
No Data
        Mixer/loader assessments are from using open mixing systems and using long pants, long-sleeve shirts, and chemical-resistant
        gloves. The application and flagger assessments are from using open tractor cabs and open cockpits, and using long pants and
        long-sleeve shirts (no gloves). The mixer/loader/applicator assessments are from using hand-held equipment and long-sleeve shirt,
        long pants, and chemical-resistant gloves.
        Potential Dally Dermal Dose = Daily Dermal Exposure/Body Weight. Default body weight is 70 kg.
        MOE « NOEL / Potential Daily Dermal Dose. NOEL, = 375 mg/kg/day (systemic NOEL from a 21-day dermal study). In
        comparison to the dermal route bf exposure, inhalation exposure is considered insignificant.
                                               30

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C.    Environmental Assessment
             Ecological Toxicity Data
             a.    Toxicity to Terrestrial Animals

                   (1)    Birds, Acute and Subacute

                          In order to establish the toxicity of norflurazon to birds,
                   the following tests are required using the technical grade
                   material: one avian single-dose oral (LDSO) study on one species
                   (preferably mallard orbobwhite quail); two subacute dietary
                   studies (LCSO) on one species of waterfowl (preferably the
                   mallard duck) and One species of upland game bird (preferably
                   bobwbite quail).
'-'"',
•Species
Mallard Duck
Mallard Duck
Bobwhite Quail

% A.I.
Technical
80
80
•" ^ •""•• ^ *
Ay^H A*a»lcOriJ:$«xtd
LDS, mg/kg
> 2510
> 1000
> 1000
^Findings
MRIDNo.
Author/Year
00048362, Fink
etal./1980
00092234
Shellenberger/1971
00092234
Shellenberger/1971
V. , , ', , "f
Toxicity
Category
Practically
Slightly toxic
SUghfly toxic
„,„ ',;
Fulfills
Guideline
Requirement
Yes
Yes for
formulated
Yes for
formulated
product
;^:<-V'T\;^?N<,
Species
Northern Bobwhite
Mallard Duck *
•.' " »s'\
<'-.-.' s ' •• >% x ^kSffe
% A.I.
Technical
Technical

LCMppm
> 10,000
> 10,000

MRIDNo.
Author/Year
00037051
Fink/1972
00077292
Fink/1972
-o^cvr^
Toxicity
Category
Practically
nontoxic
Practically
nontoxic
:-; :xv>" *
Fulfills Guideline
RCOJ nircment
Yes
Yes"
                         These results indicate that norflurazon is practically
                   nontoxic to avian species on an acute oral and subacute dietary
                   basis. The guideline requirements are fulfilled. (MKDD
                   00048362, 00037051 & 00077292)
                                  31

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 (2)    Birds, Chronic

       Avian reproduction studies are required when birds may
 be exposed to a pesticide repeatedly or continuously through
 persistence, bioaccumulation, or multiple applications; or if
 mammalian reproduction tests indicate reproductive hazard.
.Norflurazon is persistent; therefore, avian reproduction studies
 were required.

Species
Northern
Bobwhite
Mallard Duck
Northern
Bobwhite
Mallard Duck
'< t*
% AJ.
99.4
99.4
98.8
98.8
>-- '„?? **
NOEC ppm
40
40
40
40
^ ''•., - v ~ *• ~ •" '
lAieiaa S.^p«»<«cft«»5
LOEC ppm
200
200
> 40 ppm (two test
levels - 4 & 40 ppm)
> 40 ppm
to^tr^js, 	 /
Endpoints affected
Reduced hatching
success
Hatchling weight
None
None
V ',;,£;
MRID No.
Author/Year
42615301
Beavers
etal./1992
42615302
Beavers
etal./1992
00039222
Fink/1972
00037051
Fink/1972
'- ;: "?,f^
Fulfills Guideline
Requirement
Yes
Yes
No - this study will
be considered
supplemental.
No - considered
supplemental
       These studies indicate that avian reproductive effects may
 occur at levels as low as 200 ppm. The guideline requirements
 are fulfilled. (MRID 42615301 & 42615302)

 (3)    Mammals

       Wild mammal testing is required on a case-by-case basis,
 depending on the results of the lower tier studies such as acute
 and subacute testing, intended use pattern, and pertinent
 environmental fate characteristics. Acute toxicity studies show
 that norflurazon is not acutely toxic to the animals tested to date.
 Based on these conclusions and expected exposure, wild animal
 testing was not required for norflurazon.

       In most cases, an acute oral LD50 from the Agency's
 Health Effects Division (HED) is used to determine toxicity to
 mammals.  This LD50 is reported below.
                32

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' ' '" ~ .' ' - ' ' MjUBsmailiaH Acute i
Species
Rat (small mammal surrogate)
>eal5'0xfcity ESndinBS •:•-.•?.-.•
LDs,mg/kg
9300
- " ;'''
MRID#
00111612
, / ' v
Toxicity
Category
Practically
nontoxic
             The available mammalian data indicate that norflurazon
       is practically nontoxic to small mammals on an acute oral basis.
       (MRID00111612)

       (4)    Insects

             A honey bee acute contact LD50 study is required if the
       proposed use will result in honey bee exposure.
1 	 < 	 < * KoHt8r£«tJ^eciAc«tBC«wfe^Tt«scSy ^iKdte
Species
Honey Bee
%AI .
97.6 & 80
LD5,/iga.i./bee
>235&>90
(respectively)
MRIDNo.
Author/Year
00146168
Atkins/1985
9 ^ f " '
Toxicity
Category
Practically
nontoxic
', *' ' '"~
Fulfills Guideline
Requirement
Yes
             There is sufficient information to characterize norflurazon
      as practically nontoxic to bees. The guideline requirement is
      fulfilled. (MRID 00146168)

b.    Toxicity to Aquatic Animals

      (1)    Freshwater Fish

             In order to establish the toxicity of a pesticide to
      freshwater fish, the minimum data required on the technical
      grade of the active ingredient are two freshwater fish toxicity
     . studies. One study should use a cold-water species (preferably
      the rainbow trout), and the other should use a warm-water
      species (preferably the bluegill sunfish).
                     33

-------
: . ^"" ; ;•
Species
Rainbow trout
Blucgill Sunfish
Rainbow trout
Blucgill sunfish
"- 7 &;' "•, ''
%AJ.
98.6
98.6
Technical
Technical
- Fr«sliff aier I'ts
LCj, ppm a.L
8.1
16.3
N/A
N/A
hAcmeT.xid^Rndin^
MRIDNo.
Author/Year
00087863 Stall etal./
1981
00087862 Stoll et al./ 1981
00049204 Vilkas&
Seminara/1980
00048361 Vilkas &
Seminara/1980
'-'-^;V-:.-
Toricify
Category
Moderately toxic
Slightly toxic
N/A
N/A' '
' ''>/',
'.f.f.. .....•:.. ..!•'..' 	 ' 	 "..'
Fulfills Guideline
Requirement
Yes
Yes
No
No
       The results of the 96-hour acute toxicity studies indicate
that norflurazon is moderately to slightly toxic to fish. The
guideline requirements are fulfilled. (MRJDD 00087863 &
00087862)                                         '

       Data from fish early life-stage tests are required if any of
the following criteria are met:

o if the product is applied directly to water or expected to be
transported to water from the intended use site;

o if the pesticide is intended for use such that its presence in
water is likely to be continuous or recurrent, regardless of
toxicity;

o if any acute LCSO or EC50 is less than 1 mg/L;

o if the EEC in water is equal to or greater than 0.01 of any
acute EC50 or LC50 value;

o if the actual or estimated environmental concentration in water
is less than 0.01 of any acute EC50 or LCSO value and any of the
following conditions exist: a) studies of other organisms.indicate
the reproductive physiology offish and/or invertebrates  may be
affected; or b) physicochemical properties indicate cumulative
effects; or c) the pesticide is persistent in water (e.g. half-life
greater than 4 days).

Using these criteria, fish early-life stage testing was required for
norflurazon.
                34

-------

Species
Rainbow trout
Fathead Minnow

% A.I.
96.6
96.6

NOEC ppm
0.77
1.1

LOEC
ppm
1.5
2.1
Idfte+Staatr
MATC
ppm
X>.77,
2:1-
roxkftrFiadiaas '"- '"
MRID No.
Author/Year
••••••^•IM
00248839
EG&G
Bionomics/1982
00248828
EG&G
Bionomics/1982 '
,*,,/ '"'"
Endpoints
Affected
Survival &
growth of :
Weight &
length
development
' 1'"
Fulfills Guideline
Requirement
Yes ,
Yes
       The results indicate that adverse chronic effects to fish
may occur at levels as low as 1.5 ppm.  The guideline
requirement is fulfilled. (MRID 00248839 & 00248828)

(2)    Freshwater Invertebrates

       The minimum testing required to assess the hazard of a
pesticide to freshwater invertebrates is a freshwater aquatic
invertebrate toxiciry test, preferably using first in-star Daphnia
magna or early in-star amphipods, stoneflies, mayflies, or
midges.
' - ' "' '' " "" $
Species
Daphnia magna
Freaitw
% A.I.
99.4
ater Invertebrate '
EC^o ppm
>15
(NOEC = 15)
r«xld)^3Bntffa^s-x'"v
MRIDNO.
Author/Year
00035709
Vilkas/1980
^
Toiicity
Category
Slightly
toxic
, ',..
Fulfills Guideline
Reauirement
Yes
       There is sufficient information to characterize
norfiurazon as slightly toxic to aquatic invertebrates. The
guideline requirement is fulfilled.  (MRID 00035709)

       Aquatic invertebrate life-cycle tests are required if the
criteria specified for the fish early life stage test are met.
Therefore, aquatic invertebrate life-cycle testing was required.
..'..,. 	 ^ 	 ' ~' AquarttdteT<«wityFBrfniHS ', ^ • ••••••"•••''•' '"> '"
Species
Daphnia magna
% A.I.
96.6
NOEC ppm
1.0
LOEC
ppm
2.6
MATC
ppm
> 1.0, <
2.6
ACC. No.
Author/Year
FAONOR03
EG&G
Bionomics/1983
Endpoints
Affected
% survival &
offspring
production
Fulfills
Guideline
Requirement
Yes
               35

-------
       The results indicate that chronic adverse effects to aquatic
invertebrates may occur at levels as low as 2.6 ppm. The
guideline requirement is fulfilled. (ACC.# F.AONOR03)

(3)    Estuarine and Marine Animals               ,

       Acute toxicity testing with estuarine and marine
organisms is required when an end-use product is intended for
direct application to the marine/estuarine environment or is
expected to reach this environment in significant concentrations.
Norfiurazon is to be aerially applied to crops associated with
estuarine and marine habitats (citrus, cotton, cranberries and
soybeans) and it is persistent in water. Consequently,
estuarine/marine toxicity studies were required.

       The requirements under this category include a 96-hour
LCSO for an estuarine fish, a 96-hour LCSO for shrimp, and either a
48-hour embryo-larvae study or a 96-hour shell deposition study
with oysters.
: ;
Species
Atlantic oyster embryo larvae
Mysid Qdysidopsi bahla)
Sheepshead minnow
Eastern oyster shell
deposition
Grass shrimp & mud crab
f •• •• f /A. V
' ;' -V ,-»!<
% A.I.
98.8
99.4
99.4
98.6
98.8
?' •• 2- ' •••• "fzj fff '
uarine^iajHic Acirte 1
LCVEQ.Ong/L)
NOEL>10mg/L
5.53 (NOEC = 2.29)
9.58 (NOEC= 4.58)
3.8(NOEC=1.2)
N/A
$ ' J" VJ^-iit. -»i
oxicity Rndinss
MRID No.
Author/Year
00045704
Bentley/1973
42080402
ReedetaL/1991
4'2080403
Reedetal./1991
43041802
Graves &
Swigert/1993
00158302
Bentley/1973
**"%, ' w
Toriclty
Category
Slightly
toxic
Moderately
toxic
Moderately
toxic
Moderately
toxic
N/A
''"' *"&'*"'
Fulfills Guideline
Requirement
Yes
Yes
Yes
Yes
No
       There is sufficient information to characterize norfiurazon
as slightly to moderately toxic to estuarine/marine organisms.
The guideline requirement is fulfilled.  (MRID 00045704,
42080402, 42080403, & 43041802)
               36

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c.      Toxicity to Plants
       (1)    Terrestrial

             Terrestrial plant testing is required for herbicides which
       have terrestrial non-residential outdoor use patterns and meet any
       of the following criteria:

       o if the herbicide appears to move off site of application through
       volatilization (vapor pressure >1.0 x 10'5mm Hg at 25°C) or drift
       (aerial or irrigation);

       o if there are endangered or threatened plant species associated
       with the site of application.

       Tier n seedling emergence, seed germination and vegetative
       vigor toxicity data on the technical material .for the most
       sensitive species are listed below.
• ,L '»<>•"''
Species
Dicot- radish
Monocot- onion
Dicot- mustard

%A.L
99.1
98.6
98.6 ,
,'<' ' , / ' %'~ " '"
Fresh Weight
a.i/A
0.08
0.034
0.002

NOEClbs
a.i/A
0.0032 .
0.08
0.00064
•*•* "• f f f •*-.
flings * SeedfinjzEHHtrsenee
MRID
Author/Year
42080404 - Backus, 1991
43312501 -Backus, 1994
43312501 -Backus, 1994
, ' " '..''<
Fulfills
Guideline
Requirement
Yes
Yes
Yes
;-
Species
Dicot- radish

% A.I.
99.1
&OT*aEgetT*n>i!stri»IP
Radicle Length
a.L/A
0.1
NOEC Ibs
a.t/A
4.0
^*<^J*^^
Seed germination
EC^lbs
a.L/A
>100
NOEClbs
a.i/A
2.0
*d cinnitta&m:' '"' ' '"'
MRID
Author/Year
42080404 - Backus, 1991
', ' , ' '
Fulfills
Guideline
Requirement
Yes
•* ffffff ffff
Species
Dicot- cucumber
' « ' •* "
% A.I.
99.1
arg«tT«TestiMPtaBtT«teit5
Fresh weight
EC^lbs
a.i./A
0.06
NOEC Ibs
a.L/A
0.016
.aMm-***.-***
MRID
Author/Year
42080405 - Backus, 1991
,„
Fulfills
Guideline Requirement
Yes
                      37

-------
       The results indicate that exposure levels of norflurazon of
0.00065 Ibs. a.i./A. or greater may cause detrimental effects to
certain terrestrial plants. The guideline requirement for Tier n
terrestrial plant testing is fulfilled. (MRID 42080405, 42080404,
& 43312501)

(2)    Aquatic

       Aquatic plant testing is required for any herbicide which
has outdoor non-residential terrestrial uses that may move off-
site, of application by runoff or by drift (aerial or irrigation). The
following species should be tested: Kirchneria subcapitata
(formerly known as Selenastrum capricornutum), Lemna gibba,
Skeletonema costatum,  Anabaenaflos-aquae,and a freshwater
diatom.
below:
       Tier n toxicity data on the technical material are listed

Species
Lemna gibba
Kirchneria subcapitata
(formerly known as
Selenastrum
capricornutumY
..'.^r .*"...»
% A.I.
99.41
99.41
£*£*&
ppb
86
13
l^i«4S
NOEC ppb
42.2
6.23
i&Kfo
-------
2.     Environmental Fate

       a.     Environmental Fate Assessment
   r                      •  '                              -  . •  • '    ~    •
             The environmental fate of norflurazon is fairly well understood.
       In general, horflurazon may be described as a persistent and mobile
       compound. Ground water detections have been reported. Based on
       laboratory and field data, a Small-Scale Prospective Ground Water
       Monitoring study was required to better define the potential for
       norflurazon to contaminate ground water.

             The primary route of dissipation appears to be photodegradation.
       In water, norflurazon degraded when exposed to natural sunlight with a
       half-life of less than three days.  Norflurazon on soil photodegraded
       with a half-life of 12-15 days. The major degradates are desmethyl
       norflurazon, deschloroflurazon, and dimers of norflurazon. While
       photodegradation under laboratory conditions is fairly rapid, particularly
       in water, these degradative processes are mitigated somewhat under
       field conditions.  Norflurazon reaching surface water or on the soil
       surface will photodegrade to some extent.  However, it is likely that
       significant photolysis would occur only in the upper few centimeters
       because of low transmittance of UV light through soil as well as through
       natural waters with high dissolved and particulate organic loads.  Once
       the compound moves below the surface of the water column or soil,
       photodegradation will cease.      ,

            Norflurazon does not undergo hydrolysis in sterile aqueous
       solutions of pH 5, 7, and 9.  It is also persistent in aerobic soil and
      flooded aerobic sediment with half-lives'of 130 days and 6-8 months,
   ,   respectively.  The degradates desmethyl norflurazon and CO2 increased
      to 31 -3 6% and 23 -31 % at 3 65 days, respectively in the aerobic soil
      study. Under anaerobic conditions, norflurazon is even more persistent
      with a half-life of 8 months in flooded loam sediment. Based on  its
      pattern of formation and levels of accumulation, the degradate
      desmethyl norflurazon appears to-be very persistent under both aerobic
      and anaerobic conditions.

            Norflurazon can be generally characterized as mobile to very
      mobile in soil. FreundlichKads values ranged from 0.14-7.11 iri two
      sands, a sandy loam, silt loam, clay loam and four loams.  Binding
      appears to be positively correlated with organic matter, clay content,
      and cation exchange capacity. Desorption  constants ranged from 1.4 to
      10, indicating that any binding that does, occur is reversible. Higher
                            39

-------
Freundlich Kads values were found with a clay and two peat soils, (peat
soil is representative of the cranberry use area); 26, 72, and 63
respectively.                          .

       The mobility of the major degradate, desmethyl norflurazon, is
not currently well defined, except in peat soils.  Freundlich Kads were 22
and 41 for a Wisconsin peat and a Washington peat, respectively.
Based on these data, it can be concluded that desmethyl norflurazon is
not mobile in high organic content peat soils.

       The terrestrial field dissipation studies submitted to date have
been of little value in helping to assess the persistence and mobility of
norflurazon and desmethyl norflurazon in the field.  Although the
accuracy of the field data is questionable, the general indications are
that norflurazon persists longer than one year in field soil and may
potentially be mobile in  some soils.  The degradate, desmethyl
norflurazon, is also persistent and may accumulate as a result of annual
applications of norflurazon.

       Fish accumulation data have shown that norflurazon has a low
potential to bioaccumulate in bluegill sunfish. Bioconcentration factors
ranged from 6 to 8x, 16 to 28x, and 30 to 5 9x for fillet, whole fish and
viscera, respectively.

       Norflurazon can contaminate surface water at application via
spray drift. Substantial fractions of applied norflurazon could be
available for runoff for several months post-application. The relatively
low soil/water partitioning of norflurazon indicates that most of
norflurazon runoff will generally be via dissolution in runoff water
rather than via adsorption to eroding soil.  The soil/water partitioning of
norflurazon to high organic peat soils (representative of cranberry use
areas) is substantially greater such that adsorption to eroding soil may
also contribute substantially to the runoff from peat soils.

       In most of the water column in surface waters with long
hydrological residence times, norflurazon will probably be relatively
persistent due to its resistance to abiotic hydrolysis, low volatilization
potential (estimated Henry's Law constant of 2.49 X 10'10 atm*m3/mol)
and relatively low susceptibility to degradation under aerobic
conditions. Norflurazon may be even more persistent in typically
anaerobic sediments because it appears to be even less susceptible to
degradation under anaerobic conditions than under aerobic conditions.
However, the relatively low soil/water partitioning of norflurazon
                      40

-------
                     indicates that most of the norflurazon mass in surface waters will be
                     dissolved in the water cqlumn as opposed to adsorbed to suspended and
                     bottom sediment.

                            The primary degradate of norflurazon under both aerobic and
                     anaerobic conditions appears to be desmethyl norflurazon, which is
                     persistent.  Consequently, substantial amounts in terms of applied parent
                     should be available for runoff for several to many months post-
                     application.

                            Norflurazon is not currently regulated under the Safe Drinking
                     Water Act (SDWA). Therefore no MCL has been established for it and
                     water supply systems are not required to sample and analyze for it.  In
                     addition, the EPA's Office of Drinking Water has not developed any
                     health advisory levels (HALs) for norflurazon. OPP has developed an
                     estimated HAL of approximately 30 ppb that may be compared to levels
                     found in ground water reported below.1

                            Data suggest that norflurazon leaches to ground water as a result
                     of normal agricultural use. The Agency is therefore concerned about
                     the impact of nbrflurazon on ground water qualify. The registrant of
                     norflurazon is currently performing ground  water studies for the Agency
                     and the State of Florida, to better evaluate the leaching potential of the
                     herbicide. Appropriate mitigation measures, if any, will be determined
                     on the basis of the results of these studies.
   1 This estimated HAL was calculated using the NOEL (no effect level) of 3.75 mg/kg/day, assuming a 70 kg
adult, 2 liters/day drinking water, and 20% exposure due to drinking water.

         RFD= 3.75 mg/kg/dav   = 0.0375 mg/kg/day
             100 (safety factor)                                                  •            -

         DWEL= 0.04 mg/kg/dav (70 kg adulf) = 1.4 mg/L    ^
                  2 liters/day                   '                          •           ! .    .'.

       HAL= 1.4 mg/L X 20% = 0.280 mg/L = 0.028 mg/L (30 ppb)        ,
           10* .     10                                     ;  '    •  .         ,

    *For class C carcinogens, the Office of Water applies an additional 10X safely factor to provide additional
margin of safely to account for possible carcinogenic effects; The HAL is rounded off to 30 ppb.

                                           41                         .        '

-------
b.    Environmental Fate and Transport

      (1)    Degradation

             Hydrolysis

             Norflurazon does not undergo hydrolysis in sterile
      aqueous solutions of pH 5, 7, and 9.  4,5-Pyridazinyl-labeled
      [14C]norflurazon at 0.1 ppm was stable in sterile aqueous
      buffered solutions adjusted to pH 5, 7, and 9 and incubated in the
      dark at 25 °C for 30 days. During the study, norfiurazon ranged
      from 97 to 99% of the applied and the material balances ranged
      from 95 to 102% of the applied. (MRID 00146165)

             Photodegradation in Water

             Norflurazon is very susceptible to photodegradation in
      water and degrades with a half-life of 2-3 days. Pyridazinyl-
      labeled [14C]norflurazon at 1 ppm degraded with a half-life of 2-3
      days in sterile buffered aqueous solutions (pH 7) maintained at
      25 °C ± 1 °C and irradiated with natural sunlight. At 6 days
      posttreatment, 7% of the applied [14C]norflurazon remained
      undegraded in the irradiated samples compared to 95%
      undegraded in the dark control.  Non-volatile degradates
      identified in the irradiated solutions included desmethyl
      norflurazon, deschloroflurazon and dimers of norflurazon, one of
      which was found at 16% at day 6. (MRID 00148311)

             Photodegradation on Soil

             Exposure to natural sunlight enhances the degradation of
      norflurazon on soil. Pyridazinyl-labeled [14C] norflurazon at 5
      Ibs ai/A degraded with an initial half-life of 12-15 days on loam
      soil irradiated outdoors in sealed flasks with natural sunlight. At
      24 days posttreatment, 47% of the applied remained undegraded
      in the irradiated soil compared to 96% undegraded in the dark
      control. The major degradate in the irradiated soil, desmethyl
      norflurazon, was detected at a maximum 6% of the applied (days
       15-43). (MRID 00148311)
                      42

-------
 (2)    Metabolism

       Aerobic Soil Metabolism

       Norflurazon is moderately persistent in loam soil. The
 degradate desmethyl nprflurazon appears to be more persistent
 than parent. 4,5-Pyridazinyl-labeled [14C]norflurazon at 8.3
 degraded with a half-life of 130 days in loam soil incubated at
 22°C and 75% of 0.33 bar moisture. Norflurazon declined from
 99% of the applied immediately posttreatment to 12-23% at 365
 days posttreatment.  The degradate desmethyl norflurazon
 increased from 1% of the applied immediately posttreatment to
 31-36% at 365 days. At 365 days, 14CO2 totaled 23-31% of the
 applied:  (MRID 40079601)

       Anaerobic Aquatic Metabolism

       Norflurazon is persistent under anaerobic aquatic
 conditions with a half-life of approximately 8 months. 4,5-
 Pyridazinyl-labeled [14C]norflurazon at 8.3 ug/g degraded with a
 half-life of approximately 8 months in flooded loam sediment
 incubated in dim light at 22 ° C under anaerobic conditions.
 Norflurazon declined from 94% of the applied radioactivity
 immediately posttreatment to 41-45% at 365 days. The
 degradate desmethyl norflurazon reached a maximum
 concentration of 19% of the applied at 365 days. (MRID
 40079601)

       Aerobic Aquatic Metabolism

       Norflurazon is persistent under aerobic aquatic conditions
with a half-life of approximately  6-8 months. 4,5-Pyridazinyl-
labeled [14C]norfiurazon at 8.3 ng/g degraded with a half-life of
approximately 6-8 months in a flooded loam sediment incubated
in dim light at 22°C under aerobic aquatic conditions.
Norflurazon declined from 98% of the applied immediately
posttreatment to 67% at 90 days.  The degradate desmethyl
norflurazon reached a maximum concentration of 11% of the
applied at 90 days posttreatment.  (MRID 40079601)
               43

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(3)    Mobility

       Leaching and Adsorption/Desorption

       Norflurazon is mobile in some soils, particularly those
with low organic content, clay content and CEC's. Freundlich
Kads values for 14C-norflurazon were 0.716, 2.37, 2.51, 2.77, and
7.11 for a Moss Landing sand, Salinas sandy loam, Mississippi
silt loam, Mississippi sediment, and Gilroy clay loam,
respectively.  Desorption equilibrium K^ values were 1.37,
4.12, 3.56, 3.74, and 10.0 respectively. The results indicate that
norflurazon is not strongly adsorbed to the five soils tested and
may be mobile in soils, particularly those with low clay content
and cation exchange capacities (CEC's).

       In the aged study, a 30-day aerobic soil incubation of
norflurazon produced only 6% desmethyl norflurazon, with
parent comprising over 93% of the radioactivity in the extract.
This extract containing primarily norflurazon was then applied to
the batch equilibrium system.  The calculated partition
coefficients are, therefore, largely attributable to parent
norflurazon and not its major degradate. There was an
insufficient amount of desmethyl norflurazon in the system to
generate a reliable partition coefficient.  (MRID 41986904)

       Based on a batch equilibrium experiment, Freundlich Kads
values were 0.14 for a sandy soil, 1.9 for a loam sediment, 1.9-
2.3 for three loam soils, and 26 for a clay soil. Adsorption was
positively correlated with organic matter, clay content, and CE^C
based on linear regression analysis. K^ values were 3.0-4.0 for
the three loam soils, 3.5 for the sediment, and 10.1 for the clay
soil. .

       Based on a column leaching study, unaged 14C-
norflurazon was mobile in a column of loam soil leached with
deionized water over a 12-day period. 83% of the applied
norflurazon was evenly distributed throughout the upper 24 cm
of the 40 cm column after application of 51 cm of water.
However, only 0.3% of the applied was found in the leachate.
(MRID 00148312)

       The adsorption/desorption properties of 14C-desmethyl
norflurazon were characterized in two peat soils typically found
                44

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 in U.S. cranberry fields. Freundlich Kads values were 22.1 for a
 Wisconsin peat and 41.4 for a Washington peat. Freundlich K^
 values were 50.5 and 76.1 respectively. Based on these data, it
 can be concluded that 14C-desmethyl norflurazon is not mobile in
 high organic content peat soils. (MRID 43 681001)

       Freundlich Kads values for 14C-norflurazon were 72.5 and
 62.6 for Wisconsin and Washington peat soils, respectively.
 Desorption equilibrium K^ values were 17.7 and 13.9,
 respectively. These soils were collected in and are representative
 of cranberry fields in which norflurazon is used. The results
 indicate that norflurazon is not mobile in these two peat soils
 (MRID 42710901)

 (4)    Field Dissipation

       Soil Field Dissipation

       The terrestrial field dissipation studies submitted to date
 have been of little value in helping to assess the persistence and
 mobility of norflurazon and desmethyl norflurazon in the field.
 The studies were found to be unacceptable for various reasons,
 including: a) inadequate sampling intervals; b) site
 contamination; c) high variability; d) inadequate sampling depth;
 e) inadequate number of soil cores per sampling interval; and f)
 unconfirmed application rates. Although the accuracy of the
 field data is questionable, the general indications are that
 norflurazon persists longer than one year in field soil and may
 potentially be mobile in some soils.  The degradate, desmethyl
 norflurazon, is also persistent and may accumulate as a result of
 annual applications of norflurazon.

       The terrestrial field dissipation data requirement was
 waived in 1991 in favor of a small-scale prospective ground
 water monitoring study. It was concluded at that time that
 sufficient data existed that raised concern about the potential for
 norflurazon to contaminate ground water. The laboratory and
 field data, demonstrate that norflurazon is persistent and mobile
 in some soils; therefore, the results of a new field dissipation
 study would likely trigger a ground water monitoring study.  A
 properly designed study could provide new information as well
 as address the field dissipation data gaps. The study  should track
the fate of norflurazon and desmethyl norflurazon from the point
               45

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c.
of application and involve sampling soil, soil-water, and ground
water.  Sites chosen should represent all major terrestrial use
sites for norflurazon.

(5)     Accumulation

       Accumulation in Fish

       Norflurazon has a low potential to bioaccumulate in
bluegill sunfish.  In a flow-through system containing 0.13 mg
norflurazon/L, bioconcentration factors (BCF) ranged from 6 to
8x,  16 to 28x, and 30 to 59x for fillet, whole fish and viscera,
respectively. The tissue residues after 28 days of exposure were
0.95 mg/kg for fillet,  3.4 mg/kg for whole fish, and 7.7 mg/kg
for viscera. The majority of the radioactivity in edible tissue was
identified as norflurazon (50 to 57%) and desmethyl norflurazon
(33%). Norflurazon accounted for 95 to 103% of the
radioactivity in water samples.  Tissue residues decreased rapidly
during the depuration period with greater than 90%, 96%, and
97% of the radioactivity eliminated from fillet, whole fish, and
viscera, respectively, after 14 days.  (MRID 41986905)

Water Resources

(1)     Surface Water

       Norflurazon can contaminate surface water at application
via spray drift. Substantial fractions of applied norflurazon could
be available for runoff for several months post-application
(aerobic soil metabolism half-life of 130 days; miscellaneous
field data indicating extensive persistence greater than one year
post-application). Norflurazon is moderately  susceptible to
photodegradation on  soil (half-life of 12-15 days). However,
only norflurazon on foliage or within approximately the top 1
mm of soil will be exposed to sunlight, whereas reversibly bound
norflurazbn within the top 1 cm or deeper will generally be
available for runoff. The relatively low soil/water partitioning of
norflurazon (ARS/SCS database Koc of 700; Freundlich Kads
values of 0.72-7.1 and K^ values of 1.4-10) indicates that most
of norflurazon runoff will generally be via dissolution in runoff
water rather than via adsorption to eroding soil. The soil/water
partitioning of norflurazon to high organic peat soils
(representative of cranberry use areas) is  substantially greater
                      46

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 such that adsorption to eroding soil may also contribute
 substantially to the runoff from peat soils.

       Norflurazon is susceptible to direct aqueous photolysis
 (half-life of 2-3 days).  However, even in relatively clear waters,
 sunlight rapidly becomes attenuated with increasing depth.
 Consequently, the effectiveness of direct photolysis in removing
 norflurazon from surface water.is limited to the water column of
 clear shallow water bodies and to the upper portions of the water
 column in other surface waters. In most of the water column in
 surface waters with long hydrological residence times,
 norflurazon will probably be relatively persistent due to its
 resistance to abiotic hydrolysis, low volatilization potential
 (estimated Henry's Law constant of 2.49 X 10'10 atm*m3/mol)
 and relatively low susceptibility to degradation under aerobic
 conditions (aerobic aquatic metabolism half-life of 6-8 months).
 Norflurazon may be even more persistent in typically anaerobic
 sediments because it appears to be even less susceptible to
 degradation under anaerobic conditions (anaerobic aquatic
 metabolism half-life of 8 months) than under aerobic conditions.
 However, the relatively low soil/water partitioning of
 norflurazon indicates that most of the norflurazon mass in
 surface waters will be dissolved in the water column as opposed
 to adsorbed to suspended and bottom sediment.

       The primary degradate of norflurazon under both aerobic
 and anaerobic conditions appears to be desmethyl norflurazon^
which is persistent. Consequently, substantial amounts in terms
 of applied parent should be available for runoff for several to
 many months post-application. Although the soil/water
partitioning of desmethyl norflurazon has not been well
 characterized, the loss of a methyl group generally decreases the
 soil/water partitioning of compounds. Consequently, desmethyl
norflurazon may exhibit comparable to somewhat lower
 soil/water partitioning than norflurazon, as appears to be the case
for peat soils. Therefore, runoff of desmethyl norflurazon is
probably primarily via dissolution in runoff water except from
peat soils where adsorption to eroding soil may also contribute
significantly to runoff As with norflurazon, most of the
desmethyl norflurazon mass in surface waters is probably
dissolved in the water column as opposed to adsorbed to
suspended and bottom sediment.
               47

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      the S outh Florida Water Management District (Miles and
PfeufFer 1994) summarized norflurazon detections in samples
collected every two to three months from 27 surface water sites
within the SFWMD from November 1988 through November
1993. Approximately 810 samples (30 sampling intervals X 27
sites sampled/interval) were collected from the 27 sites from
November 1988 through November 1993. Norflurazon was
detected (detection limits not provided) in 7 samples at
concentrations of 0.49, 0.85, 0.82, 1.6, 1.6, 1.6, and 1.7 ug/L.
The Louisiana Department of Agriculture and Forestry sampled
32 sites once a month from May through October 1993.
Norflurazon was detected (detection limit not provided) in 20
samples at a number of locations at concentrations ranging from
0.39 to 8.39 ug/L. Of the 21 detects, 13 were > 1 ug/L of which
two (5.81 and 8.39 ug/L) were > 5 ug/L.

      The monitoring data were derived from multiple pesticide
studies. Consequently, they do not necessarily represent
watersheds where norflurazon is known to be heavily used. Also,
sampling intervals were not designed to collect samples in
response to-spray drift during norflurazon application and to
runoff events following norflurazon applications. Therefore, the
reported concentrations in Florida and Louisiana may reflect
much less exposure to norflurazon than in watersheds where it is
heavily used and less exposure than immediately following
application or during post-application runoff events.

(2)   Ground Water

      Pesticides in Ground Water Database-Few data were
included for norflurazon in the 1992 Pesticides in Ground Water
Database (PGWDB). The PGWDB indicates that 194 wells had
been tested for norflurazon, but none of the results were positive.
Of the 194 wells reported, 188 were in Texas, and 6 were in
California. The Texas monitoring program was a statewide
survey in which analysis was performed for a large suite  of
chemicals, and was in no way targeted to areas in which
norflurazon was used. In fact, norflurazon was not listed  among
the chemicals reported by well owners as having been used in
the vicinity of the sampled wells.

      Florida: In November, 1992, the registrant submitted a
6(a)2 report detailing detections of norflurazon in four Polk
               48

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             County, Florida wells. The maximum concentration was 64 ppb.
             Further detections in Polk County that occurred in August 1993
             were reported in a later 6(a)2 report. Four wells were reported to
             be contaminated with norflurazon, with a maximum detection of
             29 ppb. Norflurazon was subsequently detected in drinking water
             wells at DeSoto City, in Highlands County. The detections in
             these wells ranged to 22 ppb.

                    In response to these detections, the registrant voluntarily
             began a prospective ground-water monitoring study for the State
             of Florida in March, 1994. Preliminary results indicate that
             norflurazon has leached to ground water in wells beneath and
      .       just off the edge of the applied field at levels comparable to the
             previous detections. The concentrations detected range from 0.5
             to 21 ppb. Concentrations of norflurazon above the detection
             limit have been found to persist in some wells for more than  a
             year.

                    North Carolina: The registrant reported to the EPA in an
             April 25, 1995 6(a)2 submission that the North Carolina
             Department of Agriculture detected norflurazon in two samples
             taken from a newly installed, 18-foot deep monitoring well. The
             detections were at concentrations of 1.7 and 5.3 ppb.

                    Small-Scale Prospective Monitoring Study in light of
             norflurazon's potential to leach to ground water, the Agency
             requested in 1992 that the registrant perform a small-scale
             prospective ground-water monitoring study. They have
             submitted a protocol that reflects many revisions to the guidance
             document for prospective ground-water studies, and commenced
             work in 1995 on such a study, which is located in Macon
           /County, Georgia. No results of ground water analyses from this
             study are currently available.,

3.    Exposure and Risk Characterization    ,

      a.     Ecological Exposure and Risk Characterization

             Explanation of the Risk Quotient (RQ) and the Level of
      Concern (LOC): The Levels of Concern are criteria used to indicate
      potential risk to nontarget organisms.  The criteria indicate that a
      chemical, when used as directed, has the potential to cause undesirable
      effects on nontarget organisms.  There are two general categories of
                           49

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LOG (acute and chronic) for each of the four nontarget fauna! groups
and one category (acute) for each of two nontarget floral groups. In
order to determine if an LOG has been exceeded, a risk quotient must be
derived and compared to the LOCs. A risk quotient is calculated by
dividing an appropriate exposure estimate, e.g., the estimated
environmental concentration (EEC), by an appropriate toxicity test
effect level, e.g., the LC50. The acute effect levels typically are:

       -EC25 (terrestrial plants),
       -ECSO (aquatic plants and invertebrates),
       -LC50 (fish and birds)y and
       -LDSO (birds and mammals)

The chronic test results are the:

       -NOEL (or NOEC) for avian and mammal reproduction studies,
       and either the NOEL for chronic aquatic studies, or the
       Maximum Allowable Toxicant Concentration (MATC), which is
       the geometric mean of the NOEL and the LOEL (or LOEC) for
       chronic aquatic studies.
;                    *
       When the risk quotient exceeds the LOG for a particular
category, risk to that particular category is presumed to exist. Risk
presumptions are presented along with the corresponding LOCs.

Levels of Concern (LOC) and associated Risk Presumption
Mammals, Birds
IF THE
acute RQ^
acute RQ£

acute RQk

chronic
                   LOC
                   0.5
                   0.2

                   0.1
Fish, Aquatic invertebrates
IF THE
acute
acute RQ^
acute
                   LOC
                   0.5
                   0.1

                   0.05
PRESUMPTION
High acute risk
Risk that may be mitigated through.
restricted use
Endangered species may be
affected acutely
Chronic risk, endangered species
may be affected chronically,

PRESUMPTION
High acute risk
Risk that may be mitigated through
restricted use
Endangered species may be
affected acutely
                     50

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       chronic RQ

       Plants
       IF THE
       RQ;>
       RQ;>
Chronic risk, endangered species
may be affected chronically

PRESUMPTION           x
High risk
Endangered plants may be affected
Currently, no separate criteria for restricted use or chronic effects for plants
exist.

             (1)    Exposure and Risk to Nontarget Terrestrial Animals

                   (a)    Birds

   ,                       Norflurazon residues found on dietary food items
                   following application are compared to LCSO values to
                   predict hazard. Chronic hazard is predicted by
                   comparing the residues to the NOEC from a valid avian
                   reproduction study.

                          The maximum concentrations of norflurazon.
                   residues which may occur on selected avian dietary food
                   items following a single application of 7,86 Ibs a.i./A
                   (maximum application rate for citrus applied by ring-
                   drench method), and 3.93 Ibs a.i./A (typical maximum
                   application rate for citrus and most other use sites) are
                   provided in the table below:
...'.'.. 	 '" .. . B!rfim»4**Ea'-yi
Food items
Short Grasses
Long Grasses
Broadleaf Plants and Insects
Fruits and Pods
coKnteatsJ Concentrations OH A-vfeoi IJfefetry FoiHi llcms in PPM
EEC - 7.86
1886 '
865
1061
118
RQ
Acute
<0.19
<0.09
<0.11

-------
studies is that the LC50 is above 10,000 ppm. The acute
risk quotients in the above table, being calculated based
on an LC50 being equal to 10,000 ppm, are considered to
be greater than the actual acute risk quotients (which are
unknown) and thus are overly conservative. These risk
quotients should be viewed as the upper limit of what the
actual risk quotients could be; the actual risk quotients are
unknown and could be much less.  Thus, risk quotients
greater than the LOG for restricted use and endangered
species do not necessarily mean that risk is presumed, but
rather that acute risk to endangered species cannot be
ruled out based on the limited information available.

      The use of norflurazon at rates of 7.86 Ib a.i./A
may cause adverse effects to endangered species of birds
due to acute toxicity.  At the use rate of 3.93, the RQs
were determined to be less than 0.1, the LOG for
presuming adverse effects to these endangered species.
Therefore, the Agency concludes there will be no adverse
effects to endangered birds by uses of norflurazon which
have a maximum label rate of 3.93 Ib a.i./A or less.  This
includes the crops cotton, soybeans, and peanuts.
Although not calculated, the RQs for all terrestrial food
crop uses which have use rates up to  4 Ib a.i./A will also
be less than 0.1, thereby yielding the conclusion of no
adverse effects to endangered.species.

       Several reasons why risk to terrestrial birds and
mammals would not be as great as predicted by the RQ
method could be:  First, with the ring drench and banded
applications used on citrus, only 30% to 80% of the field
receives herbicide application.  This does not affect the
risk quotient calculations, but it does indicate a somewhat
reduced overall risk.  Second, growth of weeds is
normally prevented around the base of trees where this
herbicide would be applied.  The label for Solicam DF
states the following:

     Solicam has no post-emergence activity and will
    not control established weeds. Existing weeds
    must be mechanically removed or controlled by
    using the suitable postemergence herbicide.
        ' 52

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       It thus appears likely that around the base of trees,
 there will be little vegetation that will be directly applied
 with norflurazon. Herbivorous birds and mammals
 would be more likely to feed in areas between the tree
 rows and on field margins where growth of weeds would
 be less controlled. Species which are not herbivorous
 may be more likely to feed under the trees, but
 norflurazon concentrations on these food items are
 expected to be considerably less than on grass and
 broadleaf vegetation. Finally, residues on all wildlife
 food items are predicted to be well below the avian  ,
 dietary LCSO and the mammalian dietary LC50's estimated
 from the rat LD50. Considering these factors, it is safe to
 conclude that the use of norflurazon on citrus will not
 harm any endangered species of birds and mammals
 through acute toxicity.

       The chronic risk quotients are based on a
 definitive NOEC of 40 ppm.  These risk quotients are far
 above the LOG  for high risk. Furthermore, norflurazon is
 generally persistent in the terrestrial environment, which
 increases concern for possible chronic effects. The
 Agency thus concludes that application of liquid
 norflurazon on all sites poses a high chronic risk to birds
 and may affect avian endangered species.  This
 conclusion does not apply to application of granular
 formulations on cranberries, which is discussed below.

 (b)    Mammals

       Small mammal exposure is addressed using acute
 oral LDSO values converted to an estimated LC50 value for
 dietary exposure. The estimated LC50 is derived using the
following formula:
   n = LD
-------

Small Mammal
Meadow vole
Adult field mouse
Least shrew
,""", "'/"*/'"'&&
Body Weight in Grams
46 gms
13 gms
5 gms
wed! oa akfc'Ik**--' dMtiHa
% of Weight Eaten
Per Day
61%
16%
110%
gST •;*,*,"&'•
Food Consumed Per Day
in Grams
28.1 gms
2.1 gms
5.5 gms
* '', ' */• •• , ,t ''••
' x $ "~f ^ •
Estimated LQ, Per
Day in PPMs
15,224 ppm
57,571 ppm
8,455 ppm
be above table is based on mfonnatioa contained irPnnqplesjgjK/tenmologvby D. E. Davis and F. Golly, published by Reinnold corporation.
                                       The estimated LC50 is then compared to the
                                 residues listed above (for avian species) to calculate a risk
                                 quotient (EEC/LC50). The table below indicates the risk
                                 quotients for each of the application rates:
' •• * " ' t ' ' '., ' , s
' ' I M»tatiHM*ato J
" " ' fii&feii DU fifeta*"
Small Mammal
Meadow vole
Adult field mouse
Least shrew
Jitetafr^ftiSfc <^lto8B&f* ''''"'' '"'"' '', '" ' ' '', ''""y", '
^RQ»^SC!/li0Wiest.|^> -"',1, <' ";''";,'""''*,<,
Application Rates in Ibs. a.i./A
7.86
0.12
0.02
0.01 .
, 3.93
0.06
0.009
0.007
                                         The only current uses for which the RQs exceed
                                 the LOG for possible adverse effects to small endangered
                                 mammals are cranberries, citrus fruits, and hops when
                                 used on fine-textured soils. The arguments posed above
                                 for birds also apply to the small endangered mammals.
                                 The Agency thus concludes that the use of norflurazon
                                 will not harm endangered species of birds and mammals
                                 through acute toxicity.

                                        A separate chronic risk assessment for mammals
                                 could not be conducted due to the lack of chronic
                                 mammalian toxicity data.  An examination of the chronic
                                 risk quotients for birds, however, as derived above shows
                                 that chronic risk quotients for all food items other than
                                 fruits and pods exceed the LOG for high risk (1). As
                                 noted above, norflurazon is generally persistent in the
                                          54

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 terrestrial environment, which increases concern for
 possible chronic effects.  Therefore, the Agency
 concludes that the application of liquid norflurazon on all
 crops poses a high risk of chronic effects on birds and
 mammals, and may cause adverse chronic effects to
 endangered species of these groups.

 (c)    Risk Characterization for Cranberry Use
               Method:  The use of norflurazon on
 cranberries has been determined to be applied solely as a
 granular formulation at a maximum use rate of 8.0 Ib
 ai/A. The Agency typically assesses the risk of granular
 formulations using the exposure index of mg ai/ft2.  The
 risk quotient is calculated by dividing this value by the
 LD50 With a maximum use rate of 8.0 Ib a.i./A, the
 exposure index is calculated as follows:

 8 Ib ai/A x 453,600 mgflb x 1/43,560 A/ft2 = 83.3 mg ai/ft2.

 Since avian LD50 is >25 10 mg ai/kg body weight (bw),
 the acute risk quotient for birds and small mammals is:

       RQ = Exposure (mg ai/ft2) / (LD50 x kg of body weight)
or:
       RQ = 83.3/(2510 x kg of body weight)

For birds with body weights of 20, 180, and 1000 g, the
RQ would be 1.7, 0.18, and 0.033, respectively.

       Since the acute rat LD50 is 9300 mg ai/kg bw, the
acute risk quotient for birds and small mammals is:

       RQ=83.3/(9300x kg of body weight)'   '   •     •    -

For small mammals with body weights of 15, 35, and
1000 g, the RQ would be 0.60, 0.26, and 0.0090,
respectively.

       According to this analysis, use of granular
norflurazon at the rate of 8 Ib ai/A is expected to pose
minimal risk of acute toxicity to birds and mammals with
         55

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the exception of possible harm to small birds. Since some
of the risk quotients exceed the LOG of 0.1; however, the
possibility that endangered species of birds and mammals
may be affected, cannot be ruled out.

Number of granules method: The registrant determined
the weight of a single granule of Evital to be
approximately 0.43 g. Since Evital contains 5.0% ai, a
single granule contains 0.43 x 0.05 = 0.0215 mg of ai.
Taking the inverse of this value determines that there are
46.5 granules per gram of ai.

      The  number of granules that an animal must
consume to reach the LDSO can now be calculated with the
following formula:

# of granules = granules/mg ai x LD 5p (mg ai/kg bw) x BW (kg)

      The  number of granules that must be consumed to
reach the LDSO of norflurazon for birds (2510 mg/kg) is
shown below for birds of various weights:

      Body Weight # of Granules
        20g         2340
        180 g        '21000
       1000 g      117,000

      The  number of granules that must be consumed to
reach the LD50 of norflurazon for mammals (9300 mg/kg)
is shown below for small mammals of various weights:

      Body Weight # of Granules
         15 g         6488
        35g         15140
       1000 g        432,558

      The Agency concludes that it is highly unlikely
that an individual bird or small mammal would consume
this many granules of product in one day. Examining
similar arguments based on the percentage of body
weight consumed, the Agency concludes that it is
unlikely that birds or mammals would consume the
percentage  of their body weights necessary to reach the
LDSO.
         56

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       The above assessments show that birds and
 mammals are not likely to consume enough granular
 norflurazon product to approach an acutely toxic dose.
 The Agency therefore concludes that the use of granular
 norflurazon on cranberries will pose minimal acute risk to
 birds and mammals, and is not expected to cause adverse
 effects on endangered birds and small mammals.

       In considering chronic risk,the Agency notes
 that several special factors are associated with the
 cranberry use that may reduce the level of risk to birds
 and mammals:

       1.  Cranberries require either weekly rainfall or
       irrigation. This would likely wash much of the
       active ingredient off the granules and into the soil.
       Granules on the surface would therefore likely
       contain high concentrations of norflurazon for
       only a few days.

       2.  The cranberry plants create a dense cover
       which would restrict access of birds to norflurazon
       granules lying on the soil surface.

       3.  The granules are composed of sand. Since a
       layer of. sand is often put over the peat soil in
       cranberry bogs, the granules may be
       indistinguishable from the surrounding substrate,
       and thus less likely to be selected by birds as grit.

       Considering these factors, the Agency concludes
that the use of granular norflurazon on cranberries will
pose minimal chronic risk to birds.  There is a high
uncertainty associated with these factors, however, and
the potential exists for norflurazon to cause reproductive
effects in birds. Because of this and because the Agency
is more protective of endangered species, possible effects
on endangered species of birds and mammals cannot be
ruled out.
         57

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       (d)    Insects

             Norflurazon is practically non-toxic to honeybees.
       Therefore, insects are not likely to be adversely affected
       by the use of norflurazon.

(2)    Exposure and Risk to Nontarget Aquatic Animals

       Expected Aquatic Concentrations: Norflurazon
displays slight to moderate toxicity to most aquatic organisms
tested to date. The Agency calculated .generic EECs for
norflurazon application to citrus (7.86 and 3.93 Ibs a.i./A) and to
cranberries (8.0 Ibs a.i./A). These EECs are designed as a screen
and estimate expected concentrations from a few basic chemical
parameters and pesticide label application information.

       The GENeric Expected Environmental Concentration
Program  (GENEEC) is the model used to estimate runoff from a
ten hectare field into a one hectare by two meter deep pond.
GENEEC calculates both acute and chronic generic expected
environmental concentration (GEEC) values. It considers
reduction in dissolved pesticide concentration due to adsorption
of pesticide to soil or sediment, incorporation, degradation in soil
before washoff to a water body, direct deposition of spray drift
into the water body, and degradation of the pesticide within the
water body. It is designed to mimic a PRZM-EXAMS
simulation. Risk quotients based on refined EECs would likely
be less conservative than those based on GENEEC, while those
based on the available monitoring data may be under-protective.

       The most current usage information indicates that, for
citrus, the maximum rate of 7.86 Ibs a.i./A is only made using
ring drench practices and the maximum rate of 3.93 Ib a.i./A is
only made using banded applications. Although these banded
applications are allowed by the labels, and may even be the
typical practice, nothing on the product labels prohibits the
product from being applied at the  3.93 Ibs ai/A rate over the
entire field (i.e. a broadcast application) using a boom sprayer.
Based on the most recent usage information,  risk assessments
were thus performed using three scenarios: ring drench
applications at 7.86 Ibs a.i./A, banded applications at 3.93 Ibs
a.i./A, and broadcast spray applications at 3.93 Ibs a.i./A.
                58

-------
       The most recent usage information indicates that no more
than about 30% of the total field is treated when using a ring
drench application, and no more than 50% of the field is treated
when using a banded application. These assumptions appear to
be a reasonable for the citrus and other fruit and nut crops oh
which norflurazon is used. The area of the field treated does not
affect the terrestrial EECs, which are based on concentrations in
the treated areas, but it does affect aquatic EECs, which are
based on the total amount of active ingredient applied per acre of
field. The product labels do not allow the rate applied on any
point of land to exceed the maximum label rate, no matter what
the application method is. The maximum use rates therefore
have been multiplied by 0.3  and 0.5 when calculating aquatic
EECs for ring drench and banded applications, respectively.

       Norflurazon may be applied on citrus and other fruit and
nut crops using a low volume irrigation system. The area of the
field that is treated will vary depending on the type of irrigation
system and the age of the trees.  The Agency has made the
estimate that no more than 30% of the total area of the field will
be treated by these chemigation applications.

GENEEC Inputs for Citrus and Other Fruit and Nut Crops:
The GENEEC model was used to calculate generic EECs
(GEECs) for application to citrus and several other crops. The
maximum rate for a ring drench application to citrus is
equivalent to 7.86 x 0.3 = 2.36 Ib ai/A and 3.93 x 0.3 - 1.18 Ib
ai/A for low volume chemigation. The maximum rate for
banded applications is equivalent to 3.93 x 0.5 = 1.97 Ib ai/A
since no more than 50% of the field is treated.  Norflurazon
could conceivably be applied as a broadcast  spray over the  entire
field at the rate of 3.93 Ibs a.i./A. The input  data for the
GENEEC model for these crops were as follows:
      Rate (Ib ai/A):
            oc-
Soil K,
Solubility (ppm):
Aerobic Soil T1/2(d):
Aerobic Aquatic T1/2 (d):
Photolysis TJ/2 (d):
2.36 (citrus, ring drench)
1.18 (citrus, chemigation)
1.97 (banded)
3.93 (broadcast)
625
28
130
240
•3             •  .  .  .
               59

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      Wetted-In?
      Incorporation Depth
      Spray Drift
Yes
 0
1.0% (Ground spray)
Cranberries: The GENEEC model also was used to estimate
GEECs for cranberries.  Since it is actually applied as a sand
granule, negligible spray drift should occur.  The input data for
the GENEEC model for these crops were as follows:
      Rate (Ib ai/A):
      Soil KOC:
      Solubility (ppm):
      Aerobic Soil T1/2 (d):
      Aerobic Aquatic TJ/2 (d):
      Photolysis T1/2 (d):
      Wetted-In?
      Incorporation Depth
      Spray Drift
 8.0
1080
 28
 130
 240
  3
 No
  0
  0% (Granular)
Cotton: GEECs were also determine for use of norflurazon on
cotton using the following input values:
      Rate (Ib ai/A):
       Solubility (ppm):
       Aerobic Soil T1/2 (d):
       Aerobic Aquatic TJ/2 (d):
       Photolysis Tj/2 (d):
       Wetted-In?
       Incorporation Depth
       Spray Drift
 1.97
 625
 28
 130
 240
  3
 No
  0
  5% (Aerial spray)
       The following table outlines the Generic EECs which
were calculated for norflurazon application to citrus, cranberries,
and to cotton:
               60

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Crop •
Citrus
Citrus
Cranberries
Cotton
Citrus and
other crops
Other crops
Application
Method
Ring drench
Low volume
chemigation
Granular
Aerial spray
Banded
spray
Broadcast
ground spray
Application
Rate
dbsa-i/A)
2.3ff
1.18
8.00
1.97
1.97"
3.93
^^^^^^^^^^^^H
Number of
Application
s
1
1
1
1
1
- 1
0- ' N'O"» "^O ^ „ " •• y&« ^fe yf ^ V •• •• 'fes^J^X*"*? *"*»*.
^^^^^m^Ws^m^i^st^^^^. M
Peak
GEEC
(ppb)
42.1
21.0
94.2
37.5
35.0
70.1
4-day
GEEC
(ppb)
41.1
20.5
91.0
36.6
34.2
68.4
21-day
EEC
(ppb)
36.2
18.1
76.3
32.3
30.1
60.3
56-day
EEC
(ppb)
29.4
14.7
58.4
26.2
24.5
49.0
 Ine application rate in the wetted area is 7.86 ID ai/A.
b The application rate in the wetted area is 3.93 Ib ai/A.
                                            (a)      Freshwater Fish

                                                     The table below provides both acute and chronic
                                            risk quotients for freshwater fish.
    Crop
Application
Method
Application Rate
   flbsa.i/A)
   Acute RQ
(PeakEEC/LC.)
  , Chronic RQ
(56-dav EEC/NOEO
    Citrus"
                   Ring drench
                               2.36"
                                                                        0.0052
                                                                                                  0.038
    Citrus
                   Low volume
                   chemigation
                                                     0.0026
                                                                                0.019
    Cranberries
                   Granular
                                                  8.00
                                                                        ,0.012
                                                                                                  0.076
    Cotton
                  Aerial spray '
                               1.97
                                                     0.0046
                                                                                                  0.034
    Citrus and
    other crops
Banded spray
     1.97*
    (typical)
    0.0043
                                                                                0.032
    Other crops
Broadcast ground spray
      3;93  .
    (typical)
    0.0087
                                                                                                  0.064
 The application rate in the wetted area is 7.86 Ib ai/A.
b The application rate in the wetted area is 3.93 Ib ai/A.
                                                         61

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                                        No acute or chronic LOCs have been exceeded for
                                 freshwater fish. Therefore, the use of norflurazon is not
                                 likely to adversely affect freshwater fish.

                                 (b)    Freshwater Invertebrates

                                        The table below provides both acute and chronic
                                 RQs for freshwater invertebrates.
i $ •[
' l * <

Crop
Citrus
Citrus
Cranberries
Cotton
Citrus and
other crops
Other crops
jv\ *"^f\ :\^lifl

Application
Method
Ring drench
Low volume
chemigation
Granular
Aerial spray
Banded spray
Broadcast ground spray
ilg&^s^^llfsll^i.
C'Aw*.4ftWM5 IW^fR^AWK *:»"$
Application Rate
(Ibs a.i/A)
2.361
1.18"
8.00
1.97
i.yf
(typical)
3.93
Atypical)

Ssh^tttep iftttUJtewsSffiSssssass
Acute RQ
(PeakEEC/LQ.)
0.0028
0.0014
0.0063
0.0025
0.0023
0.0047
^•IMPlliilP^WP

Chronic RQ
(21-day EEC/NOEC)
0.036
0.018
0.076
0.032
0.030
0.060
•The application rate in the wetted area is 7.86 lb ai/A.
* The application rate in the wetted area is 3.93 lb ai/A
                                        No acute or chronic LOCs have been exceeded for
                                 freshwater invertebrates. Therefore, the use of norflurazon
                                 is not likely to adversely affect freshwater invertebrates.

                                 (c)    Estuarine and Marine Animals

                                        The following table provides acute risk quotients for
                                 estuarine and marine animals.
                                           62

-------
* fe\%* ™ ^5 ^'•SsSsS'-s % -sw-K ^ x^^Ss j^-sv^V
VssMO ^- %$ ^&vV%^^H^'>"~X3Ss&.<
Crop
Citrus
Citrus
Cranberries
Cotton
Citrus and
other crops
Other crops
Application
Method
Ring drench
Low volume
chemigation
Granular
Aerial spray
Banded spray
Broadcast ground spray
s^S> -sV •"*?&* \s^' f\^
^mnM^Att^KJ*]^^!^ &&&1
Application Rate
(Ibs a.i/A)
2.36"
1.18"
8
1.97
1.97"
(typical)
3.93
(typical)

Acute RQ (Peak EEC/LC)
Fish
0.0044
0.0022
0.0098
0^0039
0.0037
0.0073
Mollusk
0.011
0.0055
0.025
0.0099
0.0092
0.018
Shrimp
0.0076
0.0038
0017
00068
0.0063
0.013
 ine application rate mine wetted area is 7.86 lo ai/A.
b The application rate in the wetted area is 3.93 Ib ai/A.
                                 No acute LOCs have been exceeded for estuarine and
                          marine organisms. Therefore, the use of norflurazon is unlikely to
                          adversely impact estuarine/marine endangered or non-endangered
                          species.  Data were not available to assess the chronic risk to
                          estuarine and marine organisms; however, because the freshwater
                          chronic studies and the acute estuarine and marine studies indicate
                          that norflurazon has general low toxicity to aquatic organisms,
                          chronic testing on estuarine and marine organisms is not required.

                          (3)    Exposure and Risk to Nontarget Plants

                                 (a)    Terrestrial and Semi-aquatic

                                        Non-target terrestrial plants are those which inhabit
                                 non-aquatic areas. Non-target semi-aquatic plants are plants
                                 that usually inhabit low-lying wet areas that may or may not
                                 be dry in certain times of the year. These plants are not
                                 obligatory aquatic plants in that they do not live in a
                                 continuously aquatic environment.  These terrestrial and
                                 "semi-aquatic" plants are exposed to pesticides from runoff,
                                 drift or volatilization.

                                        Runoff exposure is determined from a generic EEC.
                                 This runoff is characterized as a one acre to one acre  sheet
                                 runoff to an adjacent area that impacts terrestrial plants, or a
                                           63

-------
                                  channelized runoff from 10 acres to low lying areas some
                                  distance away that impacts semi-aquatic plants.

                                         Like aquatic EEC's, EEC's for terrestrial and semi-
                                  aquatic plants are based on the average rate (Ibs ai/A)
                                  applied over the entire field, not just the area wetted.  The
                                  application rates for ring drench and banded applications
                                  were reduced by 70% and 50%, respectively, to account for
                                  the limited amount of the field that is treated.  Also, no
                                  spray drift component was included in the EEC's for crops
                                  other than cotton. Applications on citrus and other fruit and
                                  nut crops are made by boom sprayers or low-volume "micro
                                  sprinkler" or drip irrigation systems. None of these
                                  application methods are expected to result in significant
                                  spray drift. Aerial application of granular norflurazon on-
                                  cranberries is also not expected to result in significant spray
                                  drift becauseit is applied as a granule.  Aerial application to
                                  cotton may result in significant spray drift. The table below
                                  provides risk quotients for nonendangered and endangered
                                  terrestrial and semi-aquatic plants.
r ..' 	
Crop
Citrus
Citrus
Cranberries
Cotton
Citrus and
other crops
Other crops
Application Method
King drench
Low volume
chemigation
Granular
Aerial spray
Banded spray
Broadcast ground spray
Application Rate

-------
 sites, except cranberries (see below), may adversely affect
 nontarget terrestrial and semi-aquatic plants, including
 endangered species.

       The special condition of cranberry bogs, as
 discussed below, reduces the risk of norflurazon to
 nontarget plants when used on this site. Use of norflurazon
 on cranberry bogs is not expected to result in significant
 exposure to dry land terrestrial plants.  Under some
 circumstances, however, nontarget semi-aquatic plants may
 be exposed to norflurazon from water being discharged
 from cranberry bogs. The Agency therefore concludes that
 use of norflurazon on cranberries will not adversely affect
 nontarget terrestrial plants growing in adjacent dry land
 areas, but under  some circumstances may adversely affect
 semiaquatic plants, including endangered species, growing
 in wet areas.                         •

 (b)    Aquatic

       Nontarget aquatic plants may be exposed to
 norflurazon through runoff from terrestrial sites or from
 drift. In order to estimate the risk to nontarget aquatic
 plants, EECs calculated using EFED's GENEEC program
 were used to calculate risk quotients.

       In addition, the risk to aquatic plants was based on
the results for Kirchneria subcapitata because this is the
most sensitive aquatic plant tested. The table below
provides risk quotients for nonendangered and endangered
aquatic plants.
         65

-------
i1 „ ,'•' " i
Crop
Citrus
Citrus
Cranberries
Cotton
Citrus and
other crops
Other crops

Application Method
Ring drench
Low volume
chemigation
Granular
Aerial spray
Banded spray or low
volume chemigation
Broadcast ground spray

Application Rate

-------
 would not be mobile in these soils. This would further
 decrease norflurazon potential for leaving cranberry bogs
 via runoff.

       Under some conditions, cultivation practices used
 for cranberries would likely reduce the potential for
 contamination of surface water where aquatic plants may be
 affected. For example, water discharged from a flooded
 cranberry bog is often retained in a pond or reservoir to be
 reapplied to the bog. This practice would  prevent
 norflurazon from leaving the water management system and
 entering natural water.  However, in Wisconsin some
 cranberry growers use a gravity-feed system without pumps
 (Shoemaker, 1983). With  this system, water discharged
 from a flooded cranberry field may contaminate natural
 streams and wetlands lying downstream. Also, even when
 pumps are used to recycle  water, heavy rains may
 necessitate that water be released from the retaining pond.
 There is thus some potential for exposure to aquatic and
 semi-aquatic plants from runoff. This potential is reduced
 somewhat by the high degree of binding of norflurazon to
 the peat soils of cranberry bogs.

       The Agency also determined that exposure to
 nontarget areas from drift from applications on cranberry
 fields would be minimal. Norflurazon is applied to
 cranberries in a sand granule formulation which would not
 drift an appreciable distance from the site of applications.
 Furthermore, applications are made by ground broadcast or
 by helicopter. With liquid  formulations, these application
 methods result in less spray drift compared to application .
 from a fixed winged aircraft.  With a sand granular
 formulation, these methods would be expected to result in
 negligible drift.

      In conclusion, use of norflurazon on cranberries
 should not result in any appreciable exposure to nontarget
terrestrial and semiaquatic plants, either via spray drift or
runoff. The Agency therefore concludes minimal risk to
these plants. Under some circumstances, such as heavy
rainfall, some nontarget aquatic plants may be exposed to
norflurazon from water being discharged from cranberry
bogs, although in most cases there will be little exposure.
         67

-------
      (4)    Endangered Species

             The following endangered species LOCs have been
      exceeded: chronic effects on birds and mammals, and aquatic,
      semi-aquatic and terrestrial plants. The discussions above examine
      various factors that may affect exposure in characterizing the risk
      to these species.*

             When the Endangered Species Protection Program becomes
      final, limitations in the use of norflurazon may be required to
      protect endangered and threatened species, but these limitations
      have not been defined and may be formulation specific. A
      consultation with the Fish and Wildlife Service may be conducted
      in accordance with the species-based priority approach described
      in the Program. After completion of consultation, registrants will
      be informed if any required label modifications are necessary.
      Such modifications would most likely consist of the generic label
      statement referring pesticide users to use limitations contained in
      county Bulletins.

b.    Water Resources Risk Implication for Human Health

      (1)    Surface Water

             Norflurazon is not currently regulated under the Safe
      Drinking Water Act (SDWA). Therefore, no MCL has been
      established for it and water supply systems are not required to .
      sample and analyze for it. Norflurazon is not on the OPP Health
      Effects Division's list of "apparent exceeders (chronic effects and
      cancer)". For these reasons, the Agency is not recommending
      surface water monitoring at this time.

      (2)    Ground Water

             Data exist showing that norflurazon leaches to ground water
      as a result of normal agricultural use, causing concern for the
      impact of norflurazon on ground water quality.  For this reason,
      norflurazon product labels carry a ground water advisory.
      Norflurazon has been detected in ground water in Florida at
      concentrations that approach or exceed the estimated HAL 30 ppb.
      OPP has determined an estimated HAL of 30  ppb for comparison
      with levels potentially found in ground water. The registrant Has
                       68

-------
                          begun work on monitoring programs for both the State of Florida
                          and the EPA. These studies should further clarify the extent to
                          which norfiurazon can leach to ground water. The need for further
                          mitigation for ground water concerns will be evaluated as the
                          results of these studies become available.

IV.   MSK MANAGEMENT AND REREGISTRATION DECISION

      A.    Determination of Eligibility

             Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
      of relevant data concerning an active ingredient, whether products containing the active
      ingredients are eligible for reregistration.  The Agency has previously identified and
      required the submission of the generic (i.e., active ingredient specific)  data required to
      support reregistration of products containing norfiurazon as an active ingredient. The
      Agency has completed its review of these generic data, and has determined.that the data
      are sufficient to support reregistration of all products containing norfiurazon pending
      acceptance of the risk mitigation measures described in this document. Appendix B
      identifies the generic data requirements that the Agency reviewed as part of its
      determination of reregistration eligibility of norfiurazon, and lists the submitted studies
      that the Agency found acceptable.

             The data identified in Appendix B were sufficient to allow the Agency to assess
      the registered uses of norfiurazon and to determine that norfiurazon can be used without
      resulting in unreasonable adverse effects to humans and the environment when label
    .  directions, including the mitigation measures described in this document are followed.
      To ensure that the potential risks of norfiurazon are not unreasonable, the Agency is
      requiring the registrant to implement certain risk mitigation measures.  Provided that
      these risk mitigation measures are implemented, the Agency finds that all products    .
      containing norfiurazon as the active ingredient are eligible for reregistration. The
      reregistration of particular products is addressed in Section V of this document.

             The Agency made its reregistration eligibility determination based upon the target
      data base required for reregistration, the current guidelines for conducting acceptable
      studies to generate such data, published scientific literature,  etc. and the data identified in
      Appendix B. Although, the Agency has found all uses of norfiurazon are eligible for
      reregistration, it should be understood that the Agency may take appropriate regulatory
      action, and/or require the submission of additional data to support the registration of
      products containing norfiurazon, if new information comes to the Agency's attention or if
      the data requirements for registration (or the guidelines for generating such data) change.
                                          69

-------
B.     Determination of Eligibility Decision

       1.     Eligibility Decision

             Based on the reviews of the generic data for the active ingredient
       norflurazon, the Agency has sufficient information on the health effects of
       norflurazon and on its potential for causing adverse effects in fish and wildlife
       and the environment.  Although, the current uses of norflurazon exceed levels of
       concern for avian and mammalian species - chronic, and terrestrial, semi-aquatic
       and aquatic plants, the Agency concludes that all uses of products containing
       norflurazon as the active ingredient, once amended to reflect the risk mitigation
       measures imposed in this RED, are eligible for reregistration.

       2.     Eligible and Ineligible Uses

             The Agency has determined that all uses of norflurazon are eligible for
       reregistration.

C.     Regulatory Position

       The following is a summary of the regulatory positions and rationale for
norflurazon. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.

       1.     Tolerance Reassessment

             Tolerances Listed under 40 CFR S180.356:

                   The tolerances listed in 40 CFR §180.356 are for the combined
             residues of norflurazon and its desmethyl metabolite.

                   Sufficient data are available to ascertain the adequacy of the
             established tolerances listed in 40 CFR §180.356 for the following
             commodities: almonds, apples, apricots, asparagus, avocados,
             blackberries, blueberries, cherries, citrus, cottonseed, cranberries, filberts,
             grapes, hops, nectarines, peaches, peanuts, pears, pecans, plums,
             raspberries, soybeans, soybean forage and hay, walnuts, milk, and the fat,
             meat, and meat-by-products of cattle, hogs, horses, and sheep.

                   The tolerance for hops, green listed under 40 CFR § 180.356
             should be revoked and a tolerance for the RAC (hops, green and dried)
             should be appropriately listed under a separate section for regional
             registrations (40 CFR § 180.356(x)).
                                    70

-------
Tolerances Listed under 40 CFR S185.4450:

       The tolerance listed in 40 CFR §185.4450 is for the combined
residues of norflurazon and its desmethyl metabolite in dried hops.
Sufficient data are available to ascertain the adequacy of this established
tolerance. However, according to PR Notice 93-12 (12/23/93), for
regulatory purposes, hops is considered as a RAC in both the fresh (green)
and dried forms. The Agency concludes that this tolerance should be
revoked and a tolerance for the RAC (hops, green and dried) should be
cited under tolerances with regional registrations [40 CFR §180.356(x)],

Tolerances Listed under 40 CFR $186.4450:    '

       The tolerances listed in 40 CFR § 185.4450 are for the combined
residues of norflurazon and its desmethyl metabolite in citrus molasses
and dried citrus pulp. Citrus molasses is no longer considered a
significant animal feed item and therefore no tolerances are necessary on
this commodity: the current tolerance can be revoked. Norflurazon does
not concentrate in dried citrus pulp: the RAC tolerance is therefore
considered adequate to cover expected residues in dried citrus pulp and
the current tolerance for dried citrus pulp can be revoked.

New Tolerances Needed:

       Table II indicates that data on cotton gin byproducts (cotton gin
trash) are required. The data should reflect three cropfield trials on
stripped cotton and three on picked cotton and represent the major U.S.
cotton growing regions.  The registrant must propose a tolerance for this
commodity once adequate data have been submitted and evaluated.

       Residues of norflurazon and its metabolite concentrate in citrus oil.
The Agency has recommended that a maximum residue limit of 0.7 ppm
for citrus oil be proposed.                            =

       A summary of the norflurazon tolerance reassessment and
modifications in commodity definitions are presented in Table C.
                       71

-------
Table C. Tolerance Reassessment Summary
"• ^
' ,, ','.••/
-&'>
$ v°
CojBittotfitjr
*l-?v \X " " ",,,, ,
fS*f ff'>fSfff
; "Car Wai Totei^Bce
'?% ''"'*. CM****) "'-'' '
„- ; toteranc*:
;: 'JteasaesstiBfini
',;*„ „;!&&!& '' "J
- * ,'f , '' "?* ' '''';> :
"'/' "* ;,-* '//,", "I'--
C&mm^tfCvrrectC&wmadity ':
'"'- 3' ty&if&iMm *'«'''„'''' j
Tolerances listed under 40 CFR §180.356:
Almond, hulls
Almond, meat
Apricot
Apple
Asparagus
Avocado
Blackberry
Blueberry
Cattle, fat, meat, and mbyp
Cherry
Citrus fruit
Cottonseed
Cranberry
Filberts
Goats, fat, meat, and meat by-
products (mbyp)
Grape
Hogs, fat, meat, and mbyp
Hops, green
Horses, fat, meat, and mbyp
Milk
Nectarine
Pecan
Peach
Peanut
Peanut, hay
Peanut, hulls
1
0.1
0.1
0.1
0.05
0.2
0.1
0.2
0.1
0.1
0.2
0.1
0.1
0.1
0.1
0.1
0.1
1.0
0.1
0.1
0.1
0.1
0.1
0.05
, • 5.5
1.5
1
0.1
0.1
0.1
0.05
0.2
Revoke
, 0.2
0.1
0.1
0.2
0.1
0.1
0.1
0.1
0.1
0.1
Revoke
0.1
0.1
0.1
0.1
0.1
0.05
5.5
1.5

Almond




Once the 0.2 ppm tolerance for
caneberries is established,
tolerances on blackberries and
raspberries should be revoked.
-



Cotton, undelinted seeds





As hops are now considered a
RAC in both the fresh (green)
and dried forms, the 1.0 ppm
tolerance for hops, green and
the 3 ppm tolerance for hops,
dried (§185.4550) should be
revoked, and a regional 2 ppm
tolerance for hops (green and
dried) should be established in
§180.356(1).





Peanuts, nutmeat
(

                                            72

-------
f
f f f f f %
« " ' '> " ^ %
"~ , „, ,&&&tti&3fa$
Peanut, vines
Pear
Plum (fresh prune)
Poultry, fat, meat, and mbyp
Raspberry
Sheep, fat, meat, and mbyp
Soybean
Soybean forage
Soybean hay
Walnut
,, , ^ v ,
Carreai Tolerance
-, '. &!«»>, ' -
1-5
0.1
0.1
0.1
0.2
0.1
0.1
1
1
0.1
- ^fersaefeV
f fsS/S '
, Reassessment .. .
, ''''/" tftfttn) ' ',-- "
Revoke
0.1
0.1
Revoke
Revoke
0.1
0.1
1
1
0.1
/••, , ", , >,}— ' - , '*.
Cmw*m^9frec$€&xfaato^<
'^ ,..,,>,„„ Jteffofejfoft - '' /;
Peanut vines are no longer
considered to be animal feed
items ,

- •
The Agency concluded that •
poultry commodities are a 40
CFR 180.6(a)(3) situation and
the tolerances on poultry
commodities should therefore
be revoked.
Once the 0.2 ppm tolerance for
caneberries is established,
tolerances on blackberries and
raspberries should be revoked.





Tolerances listed under 40 CFR §185.4450:
Hops, dried
. / '
3
Revoke
As hops are now considered a
RAC in both the fresh (green)
and dried forms, the 1.0 ppm
tolerance for hops, green and
the 3 ppm tolerance for hops,
dried (§185.4550) should be
revoked, and a regional 2 ppm
tolerance for hops (green and
dried) should be established in
§180.356(x).
Tolerances listed under 40 CFR §186.4450:
Citrus molasses
Citrus pulp, dried
1
0.4
Revoke
Revoke
Citrus molasses is no longer
considered a significant feed
item.
Concentration does not occur in
dried citrus pulp, and the RAC
tolerance therefore adequately
covers the processed feed.
New Tolerances Required under 40 CFR §180.356 :
Caneberry
None
0.2
Must be established
73

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: • - vi':
Cotton gin by-products

None
?--4S=i'^
To be determined
3&£!^L*i
Data are required
New Regional Tolerances Required under 40 CFR §185.356(x):
Hops, green and dried
None
2
As hops are now considered a
RAC in both the fresh (green)
and dried forms, the 1.0 ppm
tolerance for hops, green and
the 3 ppm tolerance for hops,
dried (§185.4550) should be
revoked, and a regional 2 ppm
tolerance for hops (green and
dried) should be established in
§180.356(x).
New Food Additive Tolerances Required under 40 CFR §185.4450:
Citrus, oil
None
—
A, Section 701 MRL of 0.7 ppm
must be proposed.
CODEX HARMONIZATION

      No maximum residue limits (MRLs) for norflurazon have been established
by Codex for any agricultural commodity. Therefore, no compatibility issues
exist with respect to U.S. tolerances.

2.    Summary of Risk Management Decisions

      a.     Human Health

             (1)    Dietary

                   Acute Dietary

                   The Agency has evaluated the acute dietary risk associated
             with the use of norflurazon based on established and proposed
             tolerance levels and assuming 100% of each crop is treated.  The
             endpoint used is a developmental NOEL of 30 mg/kg/day, skeletal,
             variations observed at 60 mg/kg/day, in a rabbit developmental
             toxicity .study.  The MOE is 5000 for females of child-bearing age,
             the most sensitive subpopulation. MOE's of 100 or greater are
             generally considered acceptable.
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       Chronic Dietary (including cancer)

       The Agency has evaluated the chronic dietary risk
 associated with the use of norflurazon based on the same residue
 values (tolerances) and percent crop treated levels (100%) used for
 the acute dietary risk.  The RfD was established at 0.015
 mg/kg/day based upon a chronic toxicity (6 month) study in dogs
 with a NOEL of 1.58 mg/kg/day. The chronic dietary risk is
 considered to be minimal.  The chronic exposure analysis results in
 a TMRC which is 10% of the RfD for the U.S. general population.
 The subpopulation exposed the greatest is non-nursing infants (<1
 year old). This subpopulation's TMRC utilizes 47% of the RfD.
 The Agency considers exposures which utilize 100% or less of the
 RfD to be adequately protective.

       (2)    Worker (Mixer/Loader/Applicator)

       Acute (Short-Term') and Intermediate Term

       The Agency has determined that there is a potential dermal
 exposure to pesticide handlers. The endpoint used is a systemic
 NOEL of 375 mg/kg/day based on a 21-day dermal toxicity study
 in rabbits. The MOEs for short and intermediate-term occupational
 exposure subchronic systemic effects to norflurazon are greater
 than 100 for the exposure scenarios considered. For example,
 during mixing/loading, the MOEs range from 240 - 6800; these
 MOEs assume the use of long pants, long-sleeve shirts, and
 chemical-resistant gloves. During groundboom and aerial
 applications, the MOEs range from 330-4100 and during
 flagging, the MOEs range from 1400 - 1700. These MOES
 assume the use of long pants and long-sleeve shirts (no gloves).
 And, during the mixer/loader/applicator using hand held
 equipment, the MOEs are 1,339 for low pressure handwand  and
 2,206 for the backpack sprayer. These MOEs assume the use of
 long pants, long-sleeve shirt, and chemical-resistant gloves.

      Post-Application                              .

      The Agency concludes that the risks from post-application
 exposures to norflurazon would be acceptable, provided entry does
not occur immediately following application. Therefore, post-
application exposure data are not required at this time.
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             The Agency is requiring PPE which include long-sleeved
      shirt and long pants, chemical-resistant gloves, and shoes plus
      socks, as well as, requiring a REI of 12 hours.  These measures
      should be sufficient to mitigate the potential exposure to workers.

b.    Environmental

      (1)    Avian

             Acute

             The Agency has evaluated data to determine the acute
      effects of norflurazon to birds. At the use rate of 3.93 Ib a.i./A, the
      risk quotients were determined to be less than 0.1, the LOG for
      presuming adverse effects to avian endangered species. The
      Agency concludes there will be no adverse effects to endangered
      birds by uses of norflurazon which have a maximum label rate of
      3.93 Ib a.i./A or less. This rate includes the use of norflurazon on
      cotton, soybeans, and peanuts. The use of norflurazon at rates of
      7.86 Ib a.i./A may cause adverse effects to endangered species of
      birds due to acute toxicity.  This is supported by the risk quotients
      of<0.19and<0.11 which are greater than the LOG of 0.1.  Several
      reasons why risk to terrestrial birds and mammals would not be as
      great as predicted by the RQ method could be: (1) with the ring
      drench and banded applications used on citrus, only 30% to 80%
      of the  field is exposed to norflurazon; (2) growth of weeds is
      normally prevented around the base of trees where this herbicide
      would be applied; and (3) residues on all wildlife food items are
      predicted to be well below the avian dietary LCSO and the
      mammalian dietary LC50's estimated from the rat LDS0.
      'Considering these factors, it is safe to conclude that the use of
      norflurazon on citrus will not harm any endangered species of
      birds and mammals through acute toxicity.

             Norflurazon is applied to cranberries solely as a granular
      formulation. In evaluating the risk of norflurazon use on
      cranberries, the Agency concludes that it is highly unlikely that an
      individual bird or small mammal would consume enough granules
      of norflurazon product in one day so that the percentage of their
      body weights necessary to reach the LD50 would be reached.  The
      Agency concludes that the use of granular norflurazon on
      cranberries will pose minimal acute risk to birds and mammals,
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and is not expected to cause adverse effects to endangered birds
and small mammals.

       Chronic

       The Agency has evaluated data on the chronic effects of
norflurazon to birds. The chronic risk quotients for birds range
from 3 - 47 for the 7.86 Ib ai/A rate and 1 - 24 for the 3.93 Ib ai/A
rate. The Agency concludes that application of liquid norflurazon
as currently labeled on all sites, except cranberries, poses a high
chronic risk to birds and may affect avian endangered species.
Several special factors are associated with the cranberry use that
reduces the level of risk to birds: 1) the dense cover of cranberry
plants restricts the access of birds to norflurazon granules lying on
the soil surface; 2) only granular formulations of norflurazon are
applied to cranberries and granules are composed of sand which
would make them indistinguishable from the surrounding substrate
and unlikely to be selected by birds as grit; and 3) cranberries
require either weekly rainfall or irrigation, this would wash much
of norflurazon off granules and into the soil. Considering these
factors, the Agency concludes that the use of granular norflurazon
on cranberries will pose minimal chronic risk to birds.

       Although, risk reduction measures including reduced
application rates, and  use precaution statements already appear on
norflurazon product labels, a chronic risk to birds still exists. The
registrant has agreed to further mitigate the chronic risk to birds by
implementing the following measures: 1) clarifying the soil
incorporation statements on the Solicam DF and Zorial product
labels by making them more conspicuous and adding them to the
specific use directions for each crop; and 2) simplifying the use   .
directions of the Solicam DF and Zorial product labels in banded
treatments by clearly stating that no part of a field receives more
than the equivalent of the maximum broadcast rate. These
measures should reduce exposure to norflurazon for birds on both
an immediate and long term basis.

(2)    Mammals-

       Acute

       At the application rate of 7.86 Ib ai/A, the acute risk
quotients for norflurazon were determined to be 0.01, 0.02, and
                77

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 0.12 for the least shrew, adult field mouse and meadow vole,
 respectively. .At the use rate of 3.93 Ib ai/A, the acute risk
 quotients were determined to be less than 0.1.  The Agency
 concludes that the use of norflurazon will not harm mammals,
 including endangered species through acute toxicity.

       Chronic

       The Agency could not conduct a separate chronic risk
 assessment for mammals due to the lack of chronic mammalian
 toxiciry data.  An examination of the chronic risk assessment for
 birds shows that chronic risk quotients for all food items other than
 fruits and pods exceed the LOG for high risk (1). Norflurazon is
 generally persistent in the terrestrial environment, which increases
 concern for possible chronic effects. Therefore, the Agency
 concludes that the application of liquid norflurazon on all crops
 poses a high risk of chronic effects on mammals, and may cause
 adverse chronic effects to endangered species of these groups.  For
 the application of granular norflurazon on cranberries, the
 conclusions posed above on the chronic effects to birds also apply
 to mammals. Likewise, the risk mitigation measures proposed
 above for birds should also reduce the exposure of norflurazon to
 mammals.

 (3)    Insects

       Norflurazon is practically non-toxic to honeybees.
 Therefore, insects are not likely to be adversely affected by  the use
 of norflurazon.

 (4)    Freshwater Fish

       No acute  or chronic, LOCs have been exceeded for
freshwater fish. Therefore, the use of norflurazon is not likely to
 adversely affect freshwater fish.

 (5)    Aquatic invertebrates

       No acute or chronic LOCs have been exceeded for
freshwater invertebrates. Therefore, the use of norflurazon is not
likely to adversely affect freshwater invertebrates.
                78

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 (6)    Estuarine and Marine Organisms

       No acute LOCs have been exceeded for estuarine and
 marine organisms. Therefore, the use of norflurazon is unlikely to
 adversely impact estuarine/marine endangered or non-endangered
 species.  Data were not available to assess the chronic risk to
•estuarine and marine organisms. Because the freshwater chronic
 studies and the acute estuarine and marine studies indicate that   .
 norflurazon has general low toxicity to aquatic organisms, chronic
 testing on estuarine and marine organisms is not required.

 (7)    Nontarget Plant* (Terrestrial, Semi-Aquatic, and
       Aquatic)

       The Agency has evaluated data which indicate that LQCs
 are exceeded for terrestrial, semi-aquatic, and aquatic plants.
Depending on the crops, application method and application rates,
the risk quotients for terrestrial plants range from'' 1.7 - 80. The
 semi-aquatic plant risk quotient for cotton is 1.7 (this is the effect
on foliage from exposure to spray drift only). The other risk
quotients for semi-aquatic plants range from 120 - 800 depending
on the crop, application method and application rates. The risk
quotients for aquatic plants, nonendangered species range from 1.6
- 7.3, and the endangered species risk quotients range from 3.3 -
 11.1. Therefore, use of norflurazon on all sites, except cranberries,
may adversely affect nontarget terrestrial and semi-aquatic plants,  ,,
including endangered species. Considering the special conditions
of cranberry bogs, the Agency concludes that use of norflurazon on
cranberries will not adversely affect nontarget terrestrial plants
growing in adjacent dry land areas, but under some circumstances
may adversely affect semiaquatic plants, including endangered
species, growing in wet areas.

       The use of norflurazon on cranberries should not result in
any appreciable exposure to nontarget terrestrial and semiaquatic
plants, either via spray drift or runoff. The Agency therefore
concludes minimal risk to these plants.  The special condition of
cranberry bogs reduces the risk to aquatic plants for this use,site
because under some conditions cultivation practices used for  ,
cranberries would likely reduce the potential for contamination of
surface water where aquatic plants may be affected. Also,
exposure to nontarget areas from drift from applications on
cranberry fields would be minimal because norflurazon is applied
                79

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to cranberries as a sand granule formulation which would not drift
an appreciable distance from the site of applications.

       Due to the phytotoxic nature of norflurazon and its method
'of application, a spray drift advisory is being required on all
norflurazon pjoduct labels.  The Agency believes that this advisory
should reduce the risk of norflurazon to nontarget plants via drift.
In addition, spray drift studies are being required to evaluate the
exposure and risk to nontarget plants.

(8)    Endangered Species

       The Agency has concerns about the exposure of threatened
and endangered plant and animal species to norflurazon as
discussed above in the science assessment chapter.  Endangered
species LOCs have been exceeded for chronic effects on birds,
mammals, and aquatic, semi-aquatic and .terrestrial plants.

       Currently, the Agency is developing a program ("The
Endangered Species Protection Program") to identify all pesticides
whose use may cause adverse impacts on endangered and
threatened species and to implement mitigation measures that will
eliminate the adverse impacts. The program would require use
restrictions to protect endangered and threatened species at the
county level.  Consultations with the Fish and Wildlife Service
may be necessary to assess risks to newly listed species or from
proposed new uses. In the future, the Agency plans to publish a
description of the Endangered Species Program in the Federal
Register and have available voluntary county-specific bulletins.
Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label
modifications at this time through the RED. Rather, any
requirements for product use modifications will occur in the future
under the Endangered  Species Protection Program.
(9)
Surface Water
       There is a concern for norflurazon contaminating surface
water at application via spray drift and runoff.  Substantial amounts
of applied norflurazon could be available for runoff several months
postapplication.  The Agency is not requiring surface water
monitoring studies at this time; however, due to the mobility and
persistence of norflurazon and desmethyl norflurazon, a surface
                80

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             water label advisory is required.  The Agency believes that this
             advisory will reduce the risk of norflurazon contaminating surface
             water through spray drift and runoff.

             (10)   Ground Water

                    Norflurazon exhibits some of the properties and
             characteristics of chemicals that have been detected in ground
             water.  Environmental fate data suggest that norflurazon leaches to
             ground water as a result of normal agricultural use.

                    The registrant has already placed a ground water advisory
             on product labels. The Agency is requiring that the ground water
             label adivsory be maintained. Previously the Agency required the
             registrant to conduct ground water monitoring studies which are
             currently in progress. These studies will provide a better
             evaluation of the leaching potential of norflurazon, as well as,
             determine if any appropriate risk mitigation measures will be
             necessary.

3.     Spray Drift Advisory

       The Agency has been working with the Spray Drift Task Force, EPA
Regional Offices and State Lead Agencies for pesticide regulation to develop the
best spray drift management practices. The Agency is now requiring interim
measures that must be placed on product labels/labeling as specified in Section V.
Once the Agency completes its evaluation of the new data base submitted by the
Spray Drift Task Force, a membership of U.S. pesticide registrants, the Agency
may impose further refinements in spray drift management practices to further
reduce off-target drift and risks associated with this drift.

4.     Labeling Rationale

Occupational/Residential Labeling Rationale/Risk Mitigation

The Worker Protection Standard (WPS)

Scope of the WPS

       The 1992 Worker Protection Standard for Agricultural Pesticides (WPS)
established certain worker-protection requirements (personal protective
equipment, restricted  entry intervals, eta) to be specified on the label of all
products that contain uses within the scope of the WPS. Uses within the scope of
                             81

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the WPS include all commercial (non-homeowner) and research uses on farms,
forests, nurseries, and greenhouses to produce agricultural plants (including food,
feed, and fiber plants, trees, turf grass, flowers, shrubs, ornamentals^ and
seedlings). Uses within scope include not only uses on plants, but also uses on
the soil or planting medium the plants are (or will be) grown in.

       At this time some of the registered uses of norflurazon are within the
scope of the Worker Protection Standard for Agricultural Pesticides (WPS) and
some uses are outside the scope of the WPS. Those that are outside the scope of
the WPS include use:

       •on pastures or rangelands,

       •in a manner not directly related to the production of agricultural
       plants, including, for example, control of vegetation in noncrop
       areas.

Compliance With The WPS

       Any product whose labeling reasonably permits use in the production of
an agricultural plant on any farm, forest, nursery,  or greenhouse  must comply
with the labeling requirements of PR Notice 93-7, "Labeling Revisions Required
by the Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7, which reflect the requirements of EPA's labeling
regulations for worker protection statements (40 CFRpart 156, subpartK). These
labeling revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides (40 CFR part 170) and must be completed in accordance
with, and within the deadlines specified in, PR Notices 93-7, 93-11," and 95-5.
Unless otherwise specifically directed in this RED, all statements required by PR
Notices 93-7 and 93-11 are to be on the product label exactly as  instructed in
those notices.

•After April 21, 1994, except as otherwise provided in PR Notices 93-7 and
93-11, all products within the scope of those notices must bear WPS PR Notice
complying labeling when they are distributed or sold by the primary registrant or
any supplementally registered distributor. .

•After October 23, 1995, except as otherwise provided in PR Notices 93-7,
93-11, and 95-5, all products within the scope of those notices must bear WPS
PR Notice complying labeling when they are distributed or sold  by any person.
                             82

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Personal Protective Equipment/Engineering Controls for Handlers

       At this time there are no. engineering control requirements, such as closed
systems, currently required on labeling for end-use products containing
norfiurazon.

Occupational-Use Products

       For each end-use product, PPE requirements for pesticide handlers are set
during reregistration in one of two ways:

       1. If EPA determines that no regulatory action must be taken as the result
       of the acute effects or other adverse effects of an active ingredient, the
       PPE for pesticide handlers will be based on the acute toxicity of the end-
       use product. For occupational-use products, PPE must be established
       using the process described in PR Notice 93-7 or more recent EPA
       guidelines.

       2. If EPA determines that regulatory action on an active ingredient must
       be taken as the result of very high acute toxicity or to certain other adverse
       effects, such as allergic effects or delayed effects (cancer, developmental
       toxicity, reproductive  effects, etc.):
       • .    In the RED for that active ingredient, EPA may establish minimum
             or "baseline" handler PPE requirements that pertain to all or most
             end-use products containing that active ingredient.
       •     These minimum PPE requirements must be compared with the PPE
             that would be designated on the basis of the acute toxicity of the
             end-use product.
      '•     The more stringent choice for each type of PPE (i.e., body wear,
             hand protection, footwear, eyewear, etc.) must be placed on the
             label of the end-use product.                               .   .

             Personal protective equipment requirements usually are set by
       specifying one or more pre-established PPE units — sets of items that are
       almost always required together.  For example, if chemical-resistant
       gloves are required, then long-sleeve shirts, long pants, socks, and shoes
       are assumed and are also included in the required minimum attire.  If the
       requirement is for two layers of body protection (coveralls over a long- or
       short-sleeve shirt and long or short pants), the minimum must also include
       (for all handlers) chemical-resistant footwear and chemical-resistant
       headgear for overhead exposures and (for mixers, loaders, and persons
       cleaning equipment) chemical-resistant aprons.
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             EPA has determined that regulatory action regarding the
       establishment of active-ingredient-based minimum PPE requirements for
       occupational handlers must be taken for norflurazon. The exposure and
       risk assessments for occupational mixers and loaders, and occupational
       mixer/loader/applicators were based on exposure data in which the
       handlers wore chemical-resistant gloves. Therefore, EPA is requiring
       chemical-resistant gloves as the baseline (minimum) PPE requirements for
       such handlers.

Post-Application/Entry Restrictions

Occupational-Use Products (WPS Uses)

Restricted-Entry Interval:

       Under the Worker Protection  Standard (WPS), interim restricted entry
intervals (REI) for all uses within the scope of the WPS are based on the acute
toxicity of the active ingredient The toxicity categories of the active ingredient
for acute dermal toxicity, eye irritation potential, and skin irritation potential are
used to determine the interim WPS REI. If one or more of the three acute toxicity
effects are in toxicity category I, the interim WPS REI is established at 48 hours.
If none of the acute toxicity effects are in category I, but one or more of the three
is classified as category n, the interim WPS REI is established at 24 hours.  If
none of the three acute toxicity effects are in category I or n, the interim WPS
REI is established at 12 hours. A 48-hour REI is increased to 72 hours when an
organophosphate pesticide is applied outdoors in arid areas. In addition, the WPS
specifically retains two types of REI's established by the Agency prior to the
promulgation of the WPS: (1) product-specific REI's established on the basis of
adequate data, and (2) interim REI's that are longer than those that would be
established under the WPS.

       The WPS interim REI for norflurazon in effect is 12 hours. EPA notes
that the 12-hour interim WPS REI was established because EPA data indicates
that norflurazon is classified as toxicity category IV for acute dermal toxicity, eye
irritation potential, and skin irritation potential. After reviewing the probable
exposures and risks from post-application exposures to norflurazon, EPA has
determined that a 12-hour restricted-entry interval (REI) is appropriate.  Due to
the lack of post-application exposure data and the systemic dermal NOEL, EPA
has determined that norflurazon is not a candidate for an REI below 12 hours.
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       EPA notes that the WPS places very specific restrictions on entry during
restricted-entry intervals when that entry involves contact with treated surfaces.
EPA believes that these existing WPS protections are sufficient to mitigate post-
application exposures of workers who contact surfaces treated with norflurazon.

       EPA also notes that if norflurazon has been correctly incorporated, the
WPS permits workers to enter the treated area during the restricted-entry interval
without personal protective equipment or any other restriction if they are
performing tasks that do not involve contact with the soil subsurface.

Early-Entry PPE:

       The WPS establishes very specific restrictions on entry by workers to
areas that remain under  a restricted-entry interval if the entry involves contact
with treated surfaces. Among those restrictions are a prohibition of routine entry
to perform hand labor tasks and requirement that personal protective equipment
be worn.  Personal protective equipment requirements for persons who must
enter areas that remain under a restricted-entry interval are based on the toxiciry
concerns about the active ingredient. The requirements are set in one of two
ways.

       1.If EPA has no  special concerns about the acute, or other adverse
       effects of an active ingredient, it establishes the early-entry PPE
       requirements based on the acute dermal toxicity, skin irritation
       potential, and eye irritation potential of the active ingredient.

       2.ff EPA has special concerns about an active ingredient due to
       very high acute toxicity or to certain other adverse effects, such as
       allergic effects, cancer, developmental toxicity, or reproductive
       effects, it may establish early-entry PPE requirements that are more
       stringent than would be established otherwise.

       Since EPA has determined that no regulatory action must be taken due to
the acute effects or other adverse effects of norflurazon, it is establishing PPE for
dermal protection on the basis of the acute toxicity of the active ingredient.
Norflurazon is classified as toxicity category IV for acute dermal toxicity and
skin irritation potential.  Since norflurazon is classified as toxicity category IV for
eye irritation potential, no protective eyewear is required..                 ,

WPS Notification Statement

       EPA has determined that double notification is not required for
norflurazon end-use products.
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             Occupational-Use Products (NonWPS Uses)

                   Since EPA has concerns about post-application, immediate (before sprays
             have dried) exposures to persons after nonWPS occupational uses of norflurazon,
             it is establishing entry restrictions for all nonWPS occupational uses of
             norflurazon end-use products. For specific requirements, refer to Section V of
             this document.

             Additional Labeling Requirements

                   The Agency is requiring additional labeling statements to be located on all
             end-use products containing norflurazon. For the specific labeling statements,
             refer to Section V of this document.

V.    ACTIONS REQUIRED OF REGISTRANTS

      This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.

      A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

                   The generic data base supporting the reregistration of norflurazon for the
             above eligible uses has been reviewed and determined to be substantially
             complete.                  "
                   The following confirmatory data are required to support reregistration of
             norflurazon:

                   Product Chemistry
                   Acute Inhalation for Technical and 78.6% DF
                   Dermal Sensitization
                   Gene Mutation (Ames Salmonella)
                   Directions for Use - Label Amendment to include PHIs
                   Residue Analytical Methods - Animal (Radiovalidation data)
                   Cropfield Trials - Cotton Gin By-products
                   Field Rotational Crops (in progress)

                   Tier II Aquatic Plant Growth
                   Batch Equilibrium Study (Degradate)
                   Spray Drift                            .  .
                   Small Scale Ground Water Monitoring (in progress)
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       2.     Labeling Requirements for Manufacturing-Use Products

             To remain in complaince with FIFRA, manufacturing use product (MP)
       labeling must be revised to comply with all current EPA regulations, PR Notices
       and applicable policies.  The MP labeling must bear the following statement
       under Directions for Use:                               ,

             "Only for formulation into an herbicide for the following
             use(s):	"

       An MP registrant may, at his/her discretion, add one of the following statements
       to an MP label under

             "Directions for Use" to permit the reformulation of the product for
             a specific use or all additional uses supported by a formulator or
             user group:

       (a)    "This product may be used to formulate products for specific use(s)
             notlisted on the MP  label if the formulator, user group, or grower
             has complied with U.S. EPA submission requirements regarding
             support of such use(s)."                            ~

       (b)    "This product may be used to formulate products for any additional
             use(s) not listed on the MP label if the formulator, user group, or
             grower has complied with U.S. EPA submission requirements
             regarding support of such use(s)."

B.     End-Use Products

       1.     Additional Product-Specific Data Requirements

             Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
       product-specific data regarding the pesticide  after a determination of eligibility
       has been made.  The product specific data requirements are listed in Appendix D,
       the Product Specific Data Call-in Notice.

             Registrants must review previous data submissions to ensure that they
       meet current EPA acceptance criteria and if not, commit to conduct new studies.-
       If a registrant believes that previously submitted data meet current testing
       standards, then study MRID numbers should be cited according to the
       instructions in the Requirement Status and Registrants Response Form provided
       for each product
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2.    Labeling Requirements for End-Use Products

      a.     Worker Protection
                                                         -"     f
             (1)    Personal Protective Equipm ent/Entry Restrictions;
                   Labeling

             PPE Requirements for Pesticide Handlers

                   Sole-active-ingredientend-use products that contain
             norflurazon must be revised to adopt the handler personal
             protective equipment requirements set forth in this section. Any
             conflicting PPE requirements on their current labeling must be
             removed.

                   Multiple-active-ingredientend-use products that contain
             norflurazon must compare the handler personal protective
             equipment requirements set forth in this section to the PPE
             requirements on their current labeling and retain the more
             protective. For guidance on which PPE is considered more
             protective, see PR Notice 93-7.

             Products Intended Primarily for Occupational Use

             WPS and nonWPS uses

                   Minimum (baseline) PPE requirements —The minimum
             (baseline) PPE for all WPS and nonWPS uses of norflurazon end-
             use products is:

                   Applicators and other handlers must wear:
                   —long-sleeved shirt and long pants, and
                   —shoes plus socks.

                   In addition, chemical-resistant gloves* must be worn by all
             mixers** and loaders and by applicators using hand-held
             equipment, such as handwands, hoses, or nozzles.

                   * For the glove statement, use the statement established for
             norflurazon through the instructions in Supplement Three of PR
             Notice 93-7.
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       ** The word "mixer" may be removed if the product is
 formulated as "ready-to-use."               ,

       Actual end-use product PPE requirements --'The PPE
 that would otherwise be established based on the acute toxicity of
 each end-use product must be compared to the minimum (baseline)
 personal protective equipment specified above. The more
 protective PPE must be placed on the product labeling. For
 guidance on which PPE is considered more protective, see PR
 Notice 93-7."                         .

       Placement in labeling —The personal protective
 equipment must be placed on the end-use product labeling in the
 location specified in PRNotice 93-7 and the format and language
 of the PPE requirements must be the same as is specified in PR
 Notice 93-7.                          .          .

 Entry Restrictions

       Sole-active-ingredientend-use products that contain
 norfiurazon must be revised to adopt the entry restrictions set forth
 in this section. Any conflicting entry restrictions on their current
 labeling must be removed.

       Multiple-active-ingredientend-use products that contain
 norfiurazon must compare the entry restrictions set forth in this
 section to the entry restrictions on their current labeling and retain
 the more protective. A specific time-period in hours or days is
 considered more protective than "sprays have dried" or "dusts have
 settled."

Products Intended Primarily for Occupational Use

WPS uses

      Restricted-entry interval —A 12-hour restricted entry
interval (REI) is required for uses within the scope of the WPS (see
PRNotice 93-7) on all end-use products (see tests in PR Notices
93-7 and 93rl 1). This REI must be inserted into the standardized
REI statement required by Supplement Three of PRNotice 93-7.
                89

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       Early-entry personal protective equipment (PPE) —

       The PPE required for early entry is:

       —coveralls,                          --
       —chemical-resistant gloves,
       —shoes plus socks

       Placement in labeling —The REI must be inserted into the
standardized REI statement required by Supplement Three of PR
Notice 93-7. The PPE required for early entry must be inserted into
the standardized early entry PPE statement required by ^Supplement
Three of PR Notice 93-7.

NonWPS uses
                                           t

       Entry restrictions —The Agency is establishing the
following entry restrictions for all nonWPS occupational uses of
norflurazon end-use products:

       For liquid applications:
       "Do not enter or allow others to enter the
       treated area until sprays have dried."

       For granular applications:
       "Do not enter or allow others to enter the
       treated area until dusts have settled. In
       addition, if the granules are watered-in, do
       not enter or allow others to enter until the
       treated area is dry, following the watering-
       in."

(2)    Other Labeling Requirements

Products Intended Primarily for Occupational Use

       The Agency is requiring the following labeling statements
to be located on all end-use products containing norflurazon that
are intended primarily for occupational use.
                90

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 Application restrictions

 "Do not apply this product in a way that will contact
 workers or other persons, either directly or through drift.
 Only protected handlers may be in the area during
 application."

 Engineering controls            ^

 "When, handlers use closed systems, enclosed cabs,
 or aircraft in a manner that meets the requirements
 listed in the Worker Protection Standard (WPS) for
 agricultural pesticides (40 CFR 170.240(d)(4-6), the
 handler PPE requirements may be reduced or
 modified as specified in the WPS."

 User safety requirements

 "Follow manufacturer's instructions for
 cleaning/maintaining PPE. If no such instructions
 for washables, use detergent and hot water. Keep
 and wash PPE separately from other laundry."

 User safety recommendations

 • "Users should wash hands before eating, drinking,
 chewing gum, using tobacco, or using the toilet."

 • "Users should remove clothing immediately if
 pesticide gets inside.  Then wash thoroughly and put
 on clean clothing."

 • "Users should remove PPE immediately after
 handling this product. Wash the outside of gloves
 before removing. As soon as possible, wash
thoroughly and change into clean clothing."

 Optional soil incorporation statement

 "Exception: if the product is soil-injected, soil-
incorporated or watered-in, the Worker Protection
                91

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b.
Standard, under certain circumstances, allows
workers to enter the treated area if there will be no
contact with anything that has been treated."

End-Use Labeling Requirements

Soil Incorporation
      The following soil incorporation label statement must be added to
the specific use directions for each crop on the Solicam DF® product
label:

      "Solicam must be moved into the weed seed
      germination zone to be effective. If no rainfall
      occurs within 4 weeks after application, the product
      must be incorporated by flood or sprinkler
      irrigation."

      The following soil incorporation label statement must be added to
the specific use directions for each crop on the Zorial Rapid 80® product
label:               .

      "Zorial Rapid 80 must be applied and incorporated by
      tillage, irrigation or rainfall before weeds germinate."

      Banded Treatments

      The following label statement must be added in the "Application
Equipment" section of the norflurazon Solicam DF® and Zorial® labels to
clarify the formulas for the row (banded) treatment calculation:

      "The solution should be mixed to the maximum label rate
      and at no point on the fieldshould the solution be applied
      at a concentration any lower or higher than this rate."
c.
       Environmental Hazard Statements
       The following labeling statements must be added to the
"Environmental Hazards" section on all norflurazon end-use products:
                      92

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       Labeling for Wetlands

       "Do not contaminate water when disposing of equipment
       washwaters. Do not apply directly to water, or to areas
       where surface water is present or to intertidal areas below
       the mean high water mark. Do not allow this material to
       drift onto neighboring crops or noncrop areas or use in a
       manner or at a time other than in accordance with label
       directions because animal, plant or crop injury, illegal
      • residues or other undesirable results may occur."

       Labeling for Surface Water

       "Norflurazon can contaminate surface water through
       spray  drift.  Under some conditions, norflurazon
       may also have a high potential for runoff into
       surface water (primarily via dissolution in runoff
       water), for several months post-application. These
       include poorly draining or wet soils with readily
       visible slopes toward adjacent surface waters,
       frequently flooded areas, areas over-laying
       extremely shallow ground water, areas with in-field
       canals or ditches that drain to surface water, areas
       not separated from adjacent surface  waters with
       vegetated filter strips, and areas over-laying tile
       drainage systems that drain to surface water."      .

       Labeling for Ground Water

       "This chemical is known to leach through soil into
       ground water under certain conditions as a result of
       agricultural use. Use of this chemical in areas where
       soils are permeable, particularly where the water
       table is shallow, may result in ground water
       contamination."

d.     Spray Drift Labeling

       The following language must be placed on each product label that
can be applied aerially:

"Avoiding spray drift at the application site is the responsibility of the
applicator.  The interaction of many equipment-and-weather-related
                       93

-------
factors determine the potential for spray drift. The applicator is
responsible for considering all these factors when making decisions.

The following drift management requirements must be followed to avoid
off-target drift movement from aerial applications to agricultural field
crops.  These requirements do not apply to forestry applications, public
health uses or to applications using dry formulations.

1.      The distance of the outer most nozzles on the boom must not
exceed 3/4 the length of the wingspan or rotor.

2.      Nozzles must always point backward parallel with the air stream
and never be pointed downwards more than 45 degrees.

Where states have more stringent regulations, they should be observed.

The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory Information.

The following aerial drift reduction advisory information must be
contained in the product labeling:

[This section is advisory in nature and does not supersede the mandatory
label requirements.]

Information on Droplet Size

The most effective way to reduce drift potential is to apply large droplets.
The best drift management strategy is to apply the largest droplets that
provide sufficient coverage and control. Applying larger droplets reduces
drift potential, but will not prevent drift if applications are made
improperly, or under unfavorable environmental conditions (see Wind,
Temperature and Humidity, and Temperature Inversions).

Controlling Droplet Size

•      Volume - Use high flow rate nozzles to  apply the highest practical
spray volume. Nozzles with higher rated flows produce larger droplets.

•      Pressure - Do not exceed the nozzle manufacturer's recommended
pressures. For many nozzle types lower pressure produces larger droplets.
When higher flow rates are needed, use higher flow rate nozzles instead of
increasing pressure.
                       94

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•      Number of nozzles - Use the minimum number of nozzles that
provide uniform coverage.

•      Nozzle Orientation - Orienting nozzles so that the spray is released
parallel to the airstream produces larger droplets than other orientations
and is the recommended practice.  Significant deflection from horizontal
will reduce droplet size and increase drift potential.

•      Nozzle Type - Use a nozzle type that is designed for the intended
application. With most nozzle types., narrower spray angles produce
larger droplets. Consider using low-drift nozzles. Solid stream nozzles
oriented straight back produce the largest droplets and the lowest drift.

Boom  Length

For some use patterns, reducing the effective boom length to less than 3/4
of the wingspan or rotor length may further reduce drift without reducing
swath width.

Application Height

Applications should not be  made at a height greater than 10 feet above the
top of the largest plants unless a greater height is required for aircraft
safety.  Making applications at the lowest height that is safe reduces
exposure of droplets to evaporation and wind.

Swath Adjustment

When applications are made with a crosswind, the swath will be displaced
downward. Therefore, on the up and downwind edges of the field, the
applicator must compensate for this displacement by adjusting the path of
the aircraft upwind.  Swath adjustment distance should increase, with
increasing drift potential (higher wind, smaller drops, etc.)

Wind

Drift potential is lowest between wind speeds of 3-10 mph. However,
many factors, including droplet size and equipment type determine drift
potential  at any given speed. Application should be avoided below 3 mph
due to variable wind direction and high inversion potential. NOTE: Local
terrain can influence wind patterns.  Every applicator should be familiar
with local wind patterns and how they affect spray drift.
                      95

-------
             Temperature and Humidity

             When making applications in low relative humidity, set up equipment to
             produce larger droplets to compensate for evaporation. Droplet
             evaporation is most severe when conditions are both hot and dry.

             Temperature Inversions

             Applications should not occur during a temperature inversion because
             drift potential is high. Temperature inversions restrict vertical air mixing,
             which causes small suspended droplets to remain in a concentrated cloud.
             This cloud can move in unpredictable directions due to the light variable
             winds common during inversions. Temperature inversions are
             characterized by increasing temperatures with altitude and are common on
             nights with limited cloud cover and light to no wind. They begin to form
             as the sun sets and often continue into the morning. Their presence can be
             indicated by ground fog; however, if fog is not present, inversions can
             also be identified by the movement of smoke from a ground source or an
             aircraft smoke generator.  Smoke that layers and moves laterally in a
             concentrated cloud (under low wind conditions) indicates an inversion,
             while smoke that moves upward and rapidly dissipates indicates good
             vertical air mixing.

             Sensitive Areas

             The pesticide should only be applied when the potential for drift to
             adjacent sensitive areas (e.g.,  residential areas, bodies of water, known
             habitat for threatened or endangered species, non-target crops) is minimal
             (e.g., when  wind is blowing away from the sensitive areas)."
                                     \
C.    Existing Stocks

      Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell  such products
for 50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.

      The Agency has determined that registrants may distribute and sell norflurazon
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
                                   96

-------
the date of the issuance of this RED. Registrants and persons other than registrants  .
remain obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.                   '
                                   97

-------

-------
VI. APPENDICES

-------

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                               GUIDE TO APPENDIX B

Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Norflurazon covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to norflurazon in all products,
including data requirements for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

       1. Data Requirement (Column 1).  The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer to
the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.

       2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:'

                          A     Terrestrial food
                          B     Terrestrial feed
                          C     Terrestrial non-food
                          D     Aquatic food™
                          E     Aquatic non-food outdoor
                          F  „  Aquatic non-food industrial
                          G     Aquatic non-food residential
                          H     Greenhouse food
                          I     Greenhouse non-food
                          J     Forestry
                          K     Residential
                          L     Indoor food
                          M    Indoor non-food
                          N     Indoor medical
                          O     Indoor residential

       3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study.  This normally is the Master Record
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                               GUIDE TO APPENDIX C

1.     CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of all studies
       considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
       in the Reregistration Eligibility Document.  Primary sources for studies in this
       bibliography have been the body of data submitted to EPA and its predecessor agencies
       in support of past regulatory decisions. Selections from other sources including the
       published literature, in those instances where they have been considered, are included.

2.     UNITS OF ENTRY.  The unit of entry in this bibliography is called a "study". In the
       case of published materials, this corresponds closely to an article. In the case of
       unpublished materials submitted to the Agency, the Agency has sought to identify
       documents at a level parallel to the published article from within the typically  larger
       volumes in which they were submitted. Thejresiiltmg "studies" generally have a distinct
       title (or at least a single subject), can stand alone for purposes of review and can be
       described with a conventional bibliographic citation. The Agency has also attempted to
       unite basic documents and commentaries upon them, treating  them as a single  study.

3.     IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
       numerically by Master Record Identifier, or "MRID number".  This number is unique to
       the citation, and should be used whenever a specific reference is required.  It is not
       related to the six-digit "Accession Number" which has been used to identify volumes of
       submitted studies (see paragraph 4(d)(4) below for further explanation).  In a few cases,
       entries added to the bibliography late in the review may be preceded by a nine character
       temporary identifier. These entries are listed after all MRID  entries.  This temporary
       identifying number is also to be used whenever specific reference is needed.

4.     FORM OF ENTRY. In addition to the Master Record Identifier (MRID),  each entry
       consists of a citation containing standard elements followed, in the case of  material
       submitted to EPA, by a description of the earliest known submission.  Bibliographic
       conventions used reflect the standard of the American National Standards Institute
       (ANSI), expanded to provide for certain special needs.

       a     Author. Whenever the author could confidently be identified, the. Agency has
             chosen to  show a personal author. When no individual was identified,  the
             Agency has shown an identifiable laboratory or testing facility as the author.
             When no author or laboratory could be identified, the  Agency has shown the first
             submitter  as the author.

       b.     Document date.  The date of the study is taken directly from the document.
             When the date is followed by  a question mark, the bibliographer has deduced the
             date from the evidence contained in the document. When the date appears  as
             (19??), the Agency was unable to determine or estimate the date of the document..

       c.     Title. In some cases, ,it has been necessary for the Agency bibliographers to .
             create or enhance a document title. Any such editorial insertions are contained
             between square brackets.             .
                                          125

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d.     Trailing parentheses.  For studies submitted to the Agency in the past, the trailing
       parentheses include (in addition to any self-explanatory text) the following
       elements describing the earliest known submission:

       (1)    Submission date.  The date of the earliest known submission appears
             immediately following the word "received."

       (2)    Administrative number. The next, element immediately following the
             word "under" is the registration number, experimental use permit
             number, petition number, or other administrative number associated with
             the earliest known submission.

       (3)    Submitter.  The third element is the submitter:  When authorship is
             defaulted to the submitter, this element is omitted.

       (4)    Volume Identification (Accession Numbers).  The final element in the
             trailing parentheses identifies the EPA accession number of the volume in
             which the original submission of the study appears. The six-digit
             accession number  follows the symbol "CDL," which stands for "Company
             Data Library."  This accession number is in turn followed by an
             alphabetic suffix which shows the relative position  of the study within the
             volume.
                                   126

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                               BIBLIOGRAPHY
 MRID
CITATION
	     Miller, DJ. (1995) Norflurazon. CBRS Response to Registrant Comments Re:
             Nature of Residue in Ruminants, Required Nature of Residue in Swine, and
             Storage Stability Data in Poultry (GDLN 171-4(b)), CBRS No. 16123. DP
             Barcode: D218821. -From DIM to Karen Jones, Reregistration.Branch dated
             10/06/95,

00025638    Winkler, V.W.: Patel, J.R. (1980) A 14C-Norflurazon Lactating Goat Study: (I)
             Absorption, Tissue Distribution and Excretion; (D) Metabolism: Research
             Report Metabolism:  Research Report CBK 3029 VWW/JRP 80001.
             (Unpublished study received Jan 11,1980 under 9F2177; submitted by Sandoz
             Corp., Homestead, Fla.; CDL:099193-A)

00027375    Sandoz-Wander, Incorporated (1972) Analytical Method # Res-lC: Analysis of
             Cranberries for Residues of SAN 9789 and Its Desmethyl Metabolite.
             (Unpublished study received Mar 14, 1975 under 11273-EX-9; CDL:224650-I)

00031634    Winkler, V.W.; Januszanis, M.; Seckinges, A.M.; et al. (1980) Norflurazon and
             Desmethyl norflurazon Residues in Soybeans after Preplant and Pre-emergence
             Treatment with Zorial®: Research Report CBK 3030 VWW 80002.
             (Unpublished study received Feb 20, 1980 under 11273-13; submitted by
             Sandoz, Inc. Crop Protection, San Diego, Calif.; CDL:099332-D)

00031642    Sandoz, Incorporated (19??) Analysis of Norflurazon and Desmethyl norflurazon
             in Soybean Meal and Oil Fractions.  Undated analytical method 2, modification
             1. (Unpublished study received Feb 20, 1980 under 11273-13; CDL:099332-H)

0003 5709    Vilkas, A.G.; Browne, A.M. (1980) The Acute Toxicity of Norflurazon (99.4%
             Active Ingredient) to the Water Flea, Daphnia magna Straus: UCCES Project
         ,    No.  11506-16-04. (Unpublished study including letter dated May 20, 1980,
             from R.J. McCormack to R.E. Stoll, received Jun 5, 1980, under 11273-19;
             prepared by Union Carbide Corp.; submitted by Sandoz, Inc. — Crop Protection,
             San Diego, Calif:  CDL:242619-A)

00037051    Fink, R.  (1972) Final Report: Eight-Day Dietary LC50~Bobwhite Quail: Project
             No.  620-124. (Unpublished study received on unknown date under 2G1338;
             prepared by Environmental Sciences Corp.; submitted by Sandoz-Wander, Inc.,
             Homestead, Fla.; CDL: 093577-C)

00037052    Freir, L.L.; Finlayson, P.M.; Brady, S.S:; et al. (1972) Results of Tests on the
             Amount of Residue Remaining, Including a Description of the Analytical
             Method Used: [SAN 9789]. (Unpublished study received on unknown date
             under 2G1338; prepared in cooperation with Washington State Univ. and others,
             submitted by Sandoz-Wander, Inc., Homestead, Fla.; CDL:093577-D)
                                       127

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                               BIBLIOGRAPHY
 MRID
                   CITATION
00037055
00039222
00041015
00041016
00045704
00047763
00047764
Strang, R.H. (1972) A Study of the Absorption, Translocation and Metabolism
of Two Pyridazinone Herbicides (SAN 6706, SAN 9789) by Cotton, Corn and
Soybean. Doctoral dissertation, Louisiana State Univ., Dept of Plant Pathplogy.
(Unpublished study including submitter summary, received on unknown date
under 2G1338; submitted by Sandoz-Wander, Inc., Homestead, Fla.;
CDL:093577-H)

Fink, R. (1972) Final Report: One-generation Reproduction Study—Bobwhite
Quail: Project No. 620-122. (Unpublished study received Apr 10, 1980, under
11273-19; prepared by Hazelton Laboratories, submitted by Sandoz, Inc.~Crop
Protection, San Diego, Calif.; CDL:22197-B)

WARF Institute, Incorporated (19??) Compound 9789: Two-Year Feeding
Study in Mice: Appendix A; Individual Body Weights. Final Report
(Unpublished study received Aug 21, 1975, under 4F1506; submitted by
Sandoz, Inc., Homestead, Fla.; CDL:0961446-A)

WARF Institute, Incorporated (19??) Compound 9789: Two-Year Feeding
Study in Mice: Appendix B: Individual Feed Consumption; Individual Organ
Weights; Individual Organ Weight Ratios, Final Report. (Unpublished study
received Aug 21, 1975 under 4F1506; submitted by Sandoz, Inc., Homestead,
Fla.; CDL:096146-A)

Bentley, R.E. (1973) Acute Toxicity of San H9789 Technical to Atlantic Oyster
(Crassostrea virginica): Report No.  FR 74001. Final Rept. (Unpublished study
including submitter summary, received May 28, 1980, under 11273-24;
prepared by Bionomics, Inc., submitted by Sandoz, Inc.—Crop Protection,  San
Diego, Calif.; CDL:243090-A)

Strang, R.H.; Rogers, R.L. (1974) Behavior and Fate of Two Phenyl
Pyridazinone Herbicides in Cotton, Corn and Soybean: Report No. FB 74003.
Final report. Unpublished study received on under No. FB 74003. F.inal report.
(Unpublished, study including submitter summary, received May 13, 1974 under
4F1506; prepared by PPG Industries and Louisiana State Univ., Plant Pathology
Dept, submitted by Sandoz, Inc., .Homestead, Fla., CDL:094588-B)
    ii                                     •
Karapally, J.C. (1974) Metabolism of 3H-Norflurazon in Cotton, Corn, and
Soybean: Report No. JK 74005. Final report.  (Unpublished study received May
13,  1974 under 4F1506; submitted by Sandoz, Inc., Homestead, Fla.;
CDL:094588-C)
                                       128

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                                BIBLIOGRAPHY
 MRID
                    CITATION
 00047765
 00047766
 00048362
00052172
00063617
00063621
00063622
00072974
00077292
 Karapally, J.C. (1974) Metabolism of fH, MC)-Norflurazon in Rat: Report No.
 JK 74007. Final report. (Unpublished study received May 13, 1974 under
 4F1506; submitted by Sandoz, Inc., Homestead, Fla.; CDL:094588-D)

 Karapally, J.C. (1974) Rate of Degradation of 14C-Norflurazon in Soil: Report
 No. JK 74007. Interim report. (Unpublished study received May 13, 1974,
 under 4F1506; submitted by Sandoz, Inc., Homestead, Fla.; CDL: 094588-E)

 Fink, R.; Beavers, J.B.; Brown, R. (1980) Final Report: Acute Oral LD50-
 MallardDuck: Project No.  131-113. (Unpublished study receivedNov. 3, 1980,
 under 11273-24; prepared by Wildlife International, Ltd.; submitted by Sandoz, '
 Inc., Crop Protection, San Diego, Calif.; CDL:243646-A)

 Fink, R.; (1972) Final Report: One-Generation Reproduction  Study- Mallard
 Ducks: Project No. 620-123. (Unpublished study received Apr. 10, 1980, under
 11273-19; prepared by Hazelton Laboratories, submitted by Sandoz, Inc., Crop
 Protection, San Diego, Calif.; CDL:242197-A)

 Fogelman, R.W.; Tyler, H.Y. (1970): Subacute Dermal Toxicity of
 San-9789-80% WP in Rabbits: Contract No. 120-490-6-70. Final Report.
 (Unpublished study prepared by Affiliated Medical Enterprises, Inc.  and
 submitted by Sandoz, Inc.).

 Hartman, H.A.; Hrab, R. (1972): Compound 9789: Investigation of Teratogenic
 Potential in the Rat: Report No. T-1-8/7/72. (Unpublished study submitted by
 Sandoz, Inc.).                                                      "

 Gough, B.J.; Shellenberger, T.E. (1971) Letter sent to Zenas B. Noon, Jr. dated
 May 18, 1971: Acute toxicological evaluations of San-9789 with fish and
 wildlife.  (Unpublished study received Nov.  14, 1972, under 3G1310; prepared
 by Gulf South Research Institute, Atchafalaya Basin Laboratories, submitted by
 Sandoz, Inc. Homestead, Fla.; CDL:092234-F)

 Brusick, D.J. (1977) Mutagenicity Evaluation of Norflurazon: LBI Project No.
 2683. Final rept. (Unpublished study including submitter summary, received
 Jun 10, 1977 under 11273-10; prepared by Litton Bipnetics, Inc., submitted by
 Sandoz, Inc.-Crop Protection, San Diego, Calif.; CDL:230379-A)

Fink, R. (1972) Final Report: Eight-Day Dietary LCso~Mallard Ducks: Project
No. 620-125. (Unpublished study received Nov 14, 1972 under 3G1310;
prepared by Environmental Sciences Corp., submitted by Sandoz, Inc.,
Homestead, Fla.; CDL:092234-G)
                                       129

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                               BIBLIOGRAPHY
 MRID
CITATION
00079434    Sandoz, Incorporated (19??)  Zonal 80 WP Cotton Herbicide, San Diego, Calif.:
             Sandoz. (Technical Bulletin; also in unpublished submission received Jul 2,
             1981, under 11273-13; CDL:070190-A)

00079435    Winkler, V.; Patel, J.; Januszanis, M.; et al. (1981) Norflurazon and Desmethyl
             Norflurazon Residues in Soybeans after Preplant, Preemergence and Split
             Application study received Apr 23, Preemergence and Split Application
             Treatments with Zonal®: CBK Report #3041-81004. (Unpublished study
             received Jul 2, 1981 under 11273-13; submitted by Sandoz, Inc. Crop Protection,
             San Diego, Calif.; CDL:070190-C)

00080750    WARF Institute, Incorporated (1975) Compound 9789: Reproduction Studies in
             Rats and Mice: Volume I: Reproduction Studies on Rats. Final rept.
             (Unpublished study, including submitter summary, received May 8, 1975 under
             5F1602; submitted by Sandoz, Inc., Homestead, Fla.; CDL:094369-A)

00080751    WARF Institute, Incorporated (1975) Compound 9789: Reproduction Studies in
             Rats and Mice: Volume 2: Reproduction Studies in Mice.  Final rept
             (Unpublished study, including submitter summary, received May 8, 1975 under
             5F1602; submitted by Sandoz, Inc., Homestead, Fla.; CDL:094368-A)

00082019    WARF Institute, Incorporated (1975) Compound 9789: Two Year Feeding Study
             in Rats. Final rept.  (Unpublished study received May 8, 1975 under 5F1602;
             submitted by Sandoz, Inc., Homestead,  Fla.; CDL:094370-A; 094371; 094372;
             094373; 094374)

00085081    Winkler, V.W.; Patel, J.R.; Januszanis, M.; et al. (1978?) Determination of
             Norflurazon Residues in Mixed Crop Matrices. Undated method.  (Unpublished
             study retreatments with Zonal®: dated method. (Unpublished study received
             Oct 19,  1981 under 9F2253; submitted by Sandoz, Inc. Crop Protection, San
             Diego, Calif.; CDL:070401-B)

00087862    Stoll, R.E.; LeBlanc, G.A.; Sousa, J.V. (1981) Acute LC50 Toxicity Study in the
             Bluegill Sunfish on Norflurazon: EG&G Bionomics No. BK-81-7-897; Sandoz
             Project T-1638. (Unpublished study received Dec. 18, 1981, under 11273-10;
             prepared in cooperation with EG&G Bionomics, submitted by Sandoz, Inc.--
             Crop Protection, San Diego, Calif.; CDL:246430-A).

00087863    Stoll, R.E.; LeBlanc, G.A.; Sousa, J.V. (1981) Acute LCSO Toxicity Study in
             Rainbow Trout on Norflurazon: EG&G Bionomics No. BK-31-7-899; Sandoz
             Project T-1637. (Unpublished study received Dec. 18, 1981, under 11273-10;
             prepared in cooperation with EG&G Bionomics, submitted by Sandoz, Inc.~
             Crop Protection, San Diego, Calif.; CDL :24643 3 -A).
                                        130

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                               BIBLIOGRAPHY
 MRID
                    CITATION
00090786
00091053
00091055
00091056
Accession
00092234

00092285
00092290*
00092294
00092296
Bukva, N.F.; Margolin, S.; Fogleman, R.W. (1970) Dermal LDSO Test-Rabbits.
(Unpublished study received Nov 14,1972 under 3G1310; submitted by Sandoz,
Inc., Homestead, Fla.; CDL: 092233-B)

Bukva, N.F. (1970) Final Report-Primary Eye Irritation of Sandoz 9789 Tech.
in Rabbits: Contract No. 120-490-7-70. (Unpublished study received Nov. 14,
1972 under 3G1310; prepared by Affiliated Medical Enterprises, Inc., submitted
by Sandoz Inc., Homestead, Fla.; CDL:092233-C).

Fogleman, R.W. (1971) Evaluation of the Subchronic (90-day) Toxicity Effects
of SAN-9789 in Rats:  Contract No. 120-546-9-70, Final rept.  (Unpublished
study received Nov 14, 1972 under 3G1310; prepared by Affiliated Medical
Enterprises, Inc., submitted by Sandoz, Inc., Homestead, Fla.; CDL:092233-F)

Harris, D.L. (1972) 9 Month Feeding Study in Rats: F0 Generation. Final rept.
(Unpublished study received Nov 14, 1972 under 3G1310; prepared by WARF
Institute, Inc., submitted by Sandoz, Inc., Homestead, Fla.; CDL:092233-G)
Shellenberger, T.E. (See MRID 00063622 for citation)

Rogers, R.L. (1971) A Study of the Behavior of H3-SAN-6706 and
H3-S AN-9789 in Cotton Plants and Soil: Submitter Report No. FB 72004.
(Unpublished study, including sub No. FB 72004. (Unpublished study,
including submitter summary, received Nov 29, 1971 under 3G1310; prepared
by Louisiana State Univ., Plant Pathology Dept, submitted by Sandoz, Inc.,
Homestead, Fla.; CDL:092232-B)

Sandoz, Inc. (1972?) Mammalian Safety Testing (Unpublished study received
on unknown date under 3 Gl 310; CDL:09223 2-H).

Sandoz-Wander, Incorporated (1971) Analysis of Cotton Seeds for Residues of
SAN 6706, SAN 9789, and Desmethyl SAN 6706. Analytical method # res-lA
dated Aug 9 received Oct 19, 1981 under analytical method #Res-lA dated Aug
9, 1971. (Unpublished study received Nov 29, 1971 under 3G1310;
CDL:092232-L)

Sandoz, Incorporated (19??) The Behavior of Seven Chlorinated Insecticides
When Analyzed by the Method for Residues of SAN 6706 and Its Mono and
Desmethyl Metabolites: Research Report No. SanF-0046. (Unpublished study
received Nov 29, 1971 under 3G1310;  CDL: 09223 2-N)
                                       131

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                               BIBLIOGRAPHY
 MRID
CITATION
00092299    Sandoz, Incorporated (1972) Residue Analysis Data Sheet: Cottonseed.
             (Compilation; unpublished study, including report nos. SanF-0142, SanF-0141,
             SanF-0143..., received on unknown date under 3G1310; CDL:092232-Q)

00092300    Boyd, V.F. (1972) Determination of H3 SAN 9789 Residues in Whole,
             Non-delinted Cottonseed, and Cottonseed Oil and Meal: Report No. FB 72003.
             Final report. (Unpublished study received on unknown date under 3G1310;
             submitted by Sandoz, Inc., Homestead, Fla.; CDL:092232-R)

00095845 .    Yaklich, R.W. (1972) Letter sent to Frank V. Boyd dated Nov 7, 1972 [Uptake
             and translocation of 14C-9789 by the mature cranberry plant]. (U.S. Agricultural
             Research Service, Northeastern Region, New Herbicide Explorations and
             Chemonarcocide Unit; unpublished study; CDL:093577-1)

00104774    Strang, R.H.; Rogers, R.L. (19??) Preliminary Data on the Absorption,
             Translocation and Metabolism of SAN-9789 in Cotton, Corn and Soybeans:
             Submitter Report No. FB 72005.  (Unpublished study, including submitter
             summary, received Nov 29,1971 under 3G1310; prepared by Louisiana State
             Univ., Plant Pathology Dept, submitted by Sandoz, Inc., Homestead, Fla.;
             CDL:092232-C)

00106025    Winkler, V. (1982) Norflurazon and Desmethyl Norflurazon Residues in U.S.
             Fruit, Nut and Citrus Crops Treated with Solicam: CBK Report #3062/82013
             VW.  (Unpublished study received Jul 12, 1982 under 11283-19; prepared by
             Sandoz, Inc., Crop Protection, submitted by General Paint & Chemical Co.,
             Chicago, IL; CDL:247824-A)

00106036    Sandoz, Inc. (1982) Residues of Norflurazon in Pecans and Other Crops.
             (Compilation; unpublished study received Jul 12, 1982 under 11273-19;
             CDL:070971-A)

00111607    Heider, J. (1971) 9789-3H, Blood Level, Tissue Distribution and Excretion in the
             Rat: Report No. P-l-7/7/71. (Unpublished study received Aug 28, 1972 under
             3G1310; submitted by Sandoz-Wander, Inc., Homestead, FL; CDL:094124-G)

00111612    Bagdon, R E..; Krause, R.; Sabatino, A. (1972): Acute Oral Rat Toxicity, Rabbit
             Eye Irritation and Rabbit Dermal Irritation Studies of Herbicide 9789, 48-511
             and a Mixture of 95% 9789:5% 48-511: Report No. T-l-10/24/72. (Unpublished
             study prepared by Environmental Sciences Corporation, submitted by
             Sandoz-Wander, Inc.)

00111614    Klotzsche, C.; Cerioli, A. (1972) Sandoz Herbicide 9789 (Zorial): Two Weeks
             Subacute Inhalation Toxicity Study in Rats: BarichtNr. 29/72; Report No. T-l-
                                       132

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                                BIBLIOGRAPHY
 MRID
                    CITATION
             11/1/72. (Unpublished study received May 13, 1974, under<4F1506; prepared
             by Sandoz, Switz., submittedd by Sandoz-Wander, Inc., Homestead FL-
             CDL:093994-C).               -                            '   '
 00111615
 00111617
00111618
00111625
00111641
00111645
00111648
00111649
00111651
00111653
 Bagdon, R.; Morelock, J.; Meserve, D. (1973) Guinea Pig Sensitization Test of
 Herbicide 9789: T-l-5/16/73. (Unpublished study received May 13, 1974 under
 4F1506; submitted by Sandoz-Wander, Inc., Homestead, FL; CDL:093994-D)

 Harris, D.; Nees, P. (1973) Long Term Feeding Study-Rat: 1 Year Report:
 Compound 9789.  (Unpublished study received May 13, 1974 under 4F1506;
 prepared by WARF Institute, Inc., submitted by Sandoz-Wander, Inc.,
 Homestead, FL; CDL:093994-G; 093995)

 Klotzsche, C.; Carpy, S.; De Rijk; et all (1973) San 9789 (Zorial), 6 Months
 Feeding Study in Dogs: Bericht Nr. 56/73. (Unpublished study received May
 13, 1974 under 4F1506; prepared by Sandoz-Wander, Inc., Homestead  FL-
 CDL: 093995-A)

 Sandoz-Wander, Inc. (1974) Results of Residues Analyses and Description of
 Methods: Norflurazon.  (Compilation; unpublished study received May  13, 1974
 under 4F1506; CDL:094004-A)

 Sandoz, Inc. (1976) Residue Chemistry: Norflurazon on Selected Fruits  & Nuts.
 (Compilation; unpublished study received Apr 23, 1976 under 6F1778-
 CDL:095230-C)

 Sandoz, Inc. (1977) Summary of Solicam 80WP Herbicide Residue Results.
 (Compilation; unpublished study received Mar 14, 1977 under 11273-EX-13-
 CDL:096039-A)

 Sandoz, Inc. (1978) Residue Chemistry: Norflurazon. (Compilation;
unpublished study received Mar 1, 1979 under 11273-19; CDL:097834-A)

WARF Institute, Inc. (1975): Compound 9789: two Year Feeding Study in
Mice. Final Report. (Unpublished study submitted by Sandoz-Wander, Inc.).

Winkler, V.; Madrid, V. (1979) Residue Chemistry: Zorial®.  (Unpublished
study received Mar 30, 1979 under 11273-13; submitted by Sandoz, Inc., Crop
Protection, San Diego, CA; CDL:098044-A)

Sandoz, Inc. (1975) Application for Temporary Permit: Solicam 80WP
(Compilation; unpublished study received Mar 14, 1975, under 5G1600-
CDL:098180-A).
                                       133

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                               BIBLIOGRAPHY
 MRID
CITATION
00111655    Sandoz, Inc. (1974) Residues of Norflurazon in Fruits and Nuts.  (Compilation;
            unpublished study received Mar 14, 1975 under 5G1600; CDL:098180-C)

00111667    Sandoz, Inc. (1975) Residues of Norflurazon in Soybeans and Peanuts Planted as
            Rotational Crops to Cotton.  (Compilation; unpublished study received Oct 15,
            1975 under 11273-13; CDL:223878-A)

00111669    Sandoz, Inc. (1977) Norflurazon Residue Determination in Various Products.
            (Compilation; unpublished study received Jun 20, 1978 under 11273-13;
            CDL:234222-B)

00112980    Klotzsche, C. (1971) Acute Inhalation Toxicity Study with San 9789, 80%
            Wettable Powder: Report No. 25/71~Agro. (Unpublished study received Jun 1,
            1971, under 11273-EX-2; submitted by Sandoz, Inc., Crop Protection, San
            Diego, CA; CDL:095046-A)

00118047    LeBlanc, G. (1982) Early Life Stage Toxicity Study in the Fathead Minnow on
            Norflurazon: Report #BW-82-5-l 166; Sandoz Project T-1767. (Unpublished
            study received Nov 15, 1982 under 11273-13; prepared by EG&G, Bionomics,
            submitted by Sandoz, Inc., Crop Protection, San Diego, CA; CDL:248828-A).

00118048    LeBlanc, G. (1982) Early Life Stage Toxicity Study in the Rainbow Trout on
            Norflurazon: Report #BW-82-5-l 165: Sandoz Project T-1733. (Unpublished
            study received Nov 15, 1982 under 11273-13; prepared by EG&G Bionomics,
            submitted by Sandoz, Inc., Crop Protection, San Diego, CA; CDL:248829-A).

00118049    LeBlanc, G. (1982) 21-Day Chronic Toxicity Test in Daphnia magna:
            Bionomics Report #BW-82-5-l 169; Sandoz Project T-1768.,  (Unpublished study
            received Nov 15, 1982 under 11273-13; prepared by EG & G, Bionomics,
            submitted by Sandoz, Inc., Crop Protection, San Diego, CA; CDL:248830-A)

00128129    Graben, M.; Januszanis, M.; Labriola-Tompkins, E. (1983) Norflurazon and
            Desmethyl Norflurazon Residues in Grapes Treated with Solicam: CNK Report
            3080/83001.  (Unpublished study received Feb 10, 1983 under 11273-19;
            submitted by Sandoz, Inc.,Crop Protection, San Diego, CA; CDL:071403-A)

00129332    Interregional Research Project No. 4 (1982) The Results of Tests on the Amount
            of Norflurazon Residues Remaining in or on Blueberries Including a Description
            of the Analytical Method Used. (Compilation; unpublished study received May
            20, 1983 under 3E2895; CDL:071614-A)

00131027    Graben, M.; Labriola-Tompkins, E.; Januszanis, M. (1983) Norflurazon and
            Desmethyl Norflurazon Residues in Florida Citrus Treated with 8 Ib ai/a
                                        134

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                                BIBLIOGRAPHY
 MRID
                    CITATION
             Solicam: CBK Report 3090/83012. (Unpublished study received Aug 30, 1983
             under 11273-19; submitted by Sandoz, Inc., Crop Protection, San Diego  CA-
             CDL:2511157-A).
 00131151
00131152
00131238
00146165
00146168
00148311
00148312
00149768
00150191
00150867
00152751
 Hrab, R.; De Raismes, M.; Yao, C. (1983): Dose Range-finding Study of
 Norflurazon in Pregnant Rabbits: Sandoz Project No. T-1793. (Unpublished
 study submitted by Sandoz, Inc., Crop Protection).

 Hrab, R.; Halbert, F.; Quagliotti, M. et al. (1983): Investigation of Teratogenic
 Potential of Norflurazon in the Rabbit-Segment II: Sandoz Project T-1794.
 (Unpublished study submitted by Sandoz, Inc., Crop Protection).

 Interregional Research Project No. 4 (1983) The Results of Tests on the Amount
 of Residues Remaining in or on Berries Including a Description of the Analytical
 Method Used.  (Compilation; unpublished study received Oct 3, 1983 under
 4E2973; CDL:071978-A)

 Skinner, W.; Quistad, G.  (1985)  Hydrolytic Stability of Norflurazon: Report No.
 3760-22-03-85. Unpublished study prepared by Zoecon Corp. 7 p.

 Atkins, E. (1985) Letter sent to N. Galiher dated May 20, 1985: Bee adults
 toxicity dusting test summary. 17 p.

 Saunders, A.; Quistad, G. (1985) Photodegradation of Norflurazon: Report No.
 3760-22-05-85. Unpublished study prepared by Zoecon Corp.  21 p.

 Skinner, W.; Quistad, G. (1985) Adsorption, Desorption arid Mobility of
Norflurazon in Soil: Report No. 3760-22-07-85. Unpublished study prepared by
Zoecon Corp. 26 p.

 Sandoz Inc. (1985) Norflurazon Registration Standard Product  Chemistry Data.
Unpublished study. 42 p.

Harden, J. (1974) Uptake, Translocation, and Metabolism of Norflurazon in
Peanuts. Unpublished study prepared by North Carolina State University. 75 p.

Interregional Research Project No. 4 (1984) Residue Data: Norflurazon on
Asparagus and Avocado Samples. Unpublished compilation. 35 p.

Zoecon Corp. (1985) Product Chemistry: Norflurazon Technical Herbicide.
Unpublished study.  4 p.
                                        135

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r
                                            BIBLIOGRAPHY
             MRID
                   CITATION
             00152752
             00155734
             00155375
             00158302
             Accession
             00248828

             Accession
             00248839

             00260490
             40012005
             40012006
             40012007
             40012008
Graben, M. (1985) Norflurazon and Desmethyl Norflurazon Residues in Peanuts
after Zonal Pre-emergence Applications: Report No. 11011/85006. Unpublished
study prepared by Zoecon Industries. 52 p.

Putman, D. (1985): Chromosome Aberration Assay in Chinese Hamster Ovary
(CHO) Cells: Norflurazon Technical. Study No. T4030-337. (Unpublished study
prepared by Microbiological Associates Inc.).

Curren, R. (1985): Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
Norflurazon Technical. Study No. T4030/380. (Unpublished study prepared by
Microbiological Associates Inc.).

Bentiey, R. (1974) Acute Toxicity of San H9789 to Grass Shrimp (Palaemonetes
vulgaris) and Mud Crab (Neopenope texana): and Atlantic Oyster: Report No.
PB 74001.  Unpublished study prepared by Bionomics, Inc. 8 p.
EG&G Bionomics.  (See MRID 0018047 for citation)
EG&G Bionomics. (See MRID 0018048 for citation)

Saunders, A.; Skinner, W.; Reuter, C.; et al. (1985): Metabolism of Norflurazon
by Female Rats: Report No. 3760-22-01-85. (Unpublished study prepared by
Zoecon Corp.).

Skinner, W.; Sakai, D.; Quistad, G. (1986) Confined Accumulation of
Norflurazon in Rotational Crops: Project I.D. 3760-22-06-85. Unpublished
study prepared by Zoecon Research Institute.  24 p.

Quinstad, G.; Skinner, W.; Reuter, C. (1986) Metabolism of Norflurazon by
Laying Hens: Project I.D. 3760-22-12-85. Unpublished study prepared by
Zoecon Corp. 25 p.

Ali, S. (1986) Residue of Norflurazon and its Desmethyl Metabolite in Orange
Processing Fractions: Project I.D. 480148-2. Unpublished study prepared by
Sandoz Crop Protection Corp.  33 p.

Skinner, W.; Quinstad, G.; Collier, K. et al. (1986) Uptake and Metabolism of
Norflurazon by Citrus, Cotton, and Soybean: Project ID. 3760-22-04-85.
Unpublished study prepared by Zoecon Research Institute. 27 p.
                                                     136

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                                BIBLIOGRAPHY
 MRID
                     CITATION
 40012009
40079601
40079603
40157701
40429302
40587901
40765001
41107201
41762501
 Quinstad, G.; Skinner, W.; Collier, K.; etal. (1986) Metabolism of Carbon 14
 Norflurazon by a Lactating Goat: Project I.D. 3760-22-13-85. Unpublished
 study prepared by Zoecon Research Institute.  30 p.

 Kanter, C. (1986) Aerobic Soil, Aerobic Aquatic and Anaerobic Aquatic
 Metabolism of Norflurazon: Laboratory Project ID; 3760-2204-85. Unpublished
 study prepared by Zoecon Research Institute. 22 p.          -

 Graben, M. (1986) Norflurazon & Desmethyl Norflurazon Stability in Fortified
 (Apple/Milk) and Field Applied (Alfalfa) Samples: Laboratory Project ID: CBK
 11034/86013. Unpublished study prepared by Zoecon Industries. 32 p.

 Ali, S. (1987) Norflurazon: Residues of Norflurazon and Its Metabolite in Plums:
 Laboratory Project ID: 480148-5. Unpublished study prepared by Sandoz Crop
 Protection industries.  8 p.

 Ali, S. (1987) Residues of Norflurazon and Its Desmethyl Metabolite in Whole
 Seeds and Processing Fractions of Soybeans: Laboratory Project I.D.: 480148-6.
 Unpublished study prepared by Sandoz Crop Protection Corp. 69 p.
 Guirguis, A. (1988) Water Solubility of Norflurazon: Project No. 480485:
 Report No. 3.  Unpublished study prepared by Sandoz Crop Protection Corp.
 P-                                                       .
                                                                                 12
41762503
 Ali, S. (1988) Determination of Norflurazon and Its Desmethyl Metabolite in
, Raw Agricultural Commodities: Laboratory Project I.D. AM-0820. Unpublished
 study prepared by Sandoz Crop Protection Corp. 43 p.

 Butz, R.; Ali, F. (1989) Field Metabolism of Norflurazon in Alfalfa: Project No.
 480485: Report No. 6. ^Unpublished study prepared by Sandoz Crop Protection
 Corp. prepared by SanSoz Crop Protection Corp. 86 p.     l

 Quistad, G. (1990) Metabolism of [Carbon 14]Norflurazon by a Lactating Goat:
 Lab Project Number: 480485:  10. Unpublished study Prepared by Sandoz Crop
 Protection Cy Biochemistry Dept, Prepared by Sandoz Crop Protection Corp.
 66 p.                                                  ,

 Skinner, W.; Quistad, G; Collier, K.; et al. (1990) Uptake and Metabolism of
 Norflurazon by Citrus, Cotton, and Soybean: Lab Project Number: 480485: 11.
 Unpublished study prepared by Sandoz Crop Protection Corp. 66 p.
                                        137

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                               BIBLIOGRAPHY
 MRID
CITATION
41762504   Butz, R.; All, F. (1989) Field Metabolism of Norflurazon in Alfalfa: Lab Project
            Number: 480485: 6. Unpublished study prepared by Sandoz Crop Protection
            Corp.  158 p.

41986902   Liu, J. (1991) Stability of Technical Norflurazon: Lab Project Number: 480483:
            3: 300379.  Unpublished study prepared by Sandoz Crop Protection Corp. 57 p.

41986903   Schimelfining, S. (1991) PR Notice 88-5 Enforcement Method Validation for
            Norflurazon and Desmethyl Norflurazon in Plant Material: Lab Project Number:
            24911TBA: PAL-AL-91-120. Unpublished study prepared by Pan-Agricultural
            Laboratories, Lie. 242 p.

41986904   Skinner, W.; Dennis, P.  (1991) Adsorption-Desorption of Norflurazon and Aged
            Norflurazon Rsidues in Soil: Lab Project Number: 480485 : 12: DP-300376.
            Unpublished study prepared by Sandoz Crop Protection Corp.  57 p.

41986905   Guirguis, A.; Yu, C. (1991) Norflurazon: Bioconcentration and Metabolism in
            Bluegill Sunfish: Lab Project Number: 480485: 13: DP300300. Unpublished
            study prepared by ABC  Laboratories, Inc. 66 p.

42056301   Cichock, G. (1991) Preliminary Analysis of Technical Norflurazon: Lab Project
            Number: 480483: 2: DP 300378. Unpublished study prepared by Sandoz Crop
          .  Protection Corp. 75 p.

42080401   Srnak, Z.; Belkind, B.; Atallah, H. (1991) Nitrosamines in Technical
            Norflurazon: Lab Project Number: DP 300636: 480483.  Unpublished study
            prepared by Thermedics Inc. 210 p.

42080402   Reed, D.; Peters, G. (1991) Norflurazon Technical: A 96-Hour FlowThrough
            Acute Toxicity Test With the Saltwater Mysid (Mysidopsis bahia): Final Report:
            Lab Project Number: 131A-106A. Unpublished study prepared by Wildlife
          , International, Ltd. 46 p.

42080403   Reed, D.; Peters, G. (1991) Norflurazon Technical: A 96-Hour FlowThrough
            Acute Toxicity Test With the Sheepshead Minnow (Cyprinodon variegatus):
            Final Report: Lab Project Number:  131A-107. Unpublished study prepared by
            Wildlife International, Ltd. 47 p.

42080404   Backus, P.  (1991) Effect of Norflurazon on Seed Germination/Seedling
            Emergence (Tier II): Report Addendum: Lab Project Number:
            3805-91-0009-BE-OO1-002. Unpublished study prepared by Ricerca, Inc. 337
            P-
                                        138

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                                BIBLIOGRAPHY
 MRID
                     CITATION
42080405
42080406
42080407
42378301
42471201
42495801
42615301
42615302
42625101
 Backus, P. (1991) Effect of Norflurazon on Vegetative Vigor of Plants (Tier n):
 Report Addendum: Lab Project Number: 5-910010-BE-OO1-002. Unpublished
 study prepared by Ricerca, Inc. 141 p.

 Hughes, J.; Alexander, M. (1991) The Toxicity of Norflurazon to Selenastrum
 capricornutum: Lab Project Number: B462-06-1.  Unpublished study prepared
 by Malcolm Pirnie, Inc. 35 p.                  -   -                     .

 Hughes, J.; Alexander, M. (1991) The Toxicity of Norflurazon to Lemna gibba
 G3: Lab Project Number: B462-06--2. Unpublished study prepared by Malcolm
 Pirnie, Inc. 34 p.

 Biehn, W. (1992) Norflurazon: Magnitude of Residue on Hops: Lab Project
 Number: IR-4 PR NO. 4095. Unpublished study prepared by Washington State
 Dept. of Agriculture Laboratory Services Division Agricultural Chemical & Hop
 Laboratory. 73 p.

 Skinner, W.; Dennis, P. (1992) Metabolites of [Phenylcarbon 14] Norflurazon in
 Peanuts, Cotton, and Citrus: Final Report: Lab Project Number: DP-300-99 Lab
 Project Number: DP-300-990. Unpublished study prepared by Sandoz Agro,
 Inc.  169 p.                                   ,

 Bregger, T. (1992) Magnitude of Norflurazon and Desmethyl Norflurazon
 Residues in Processing Fractions of Cotton: Lab Project Number: 1691-5Z:
 91-0010: 233/91/1. Unpublished study prepared by Sandoz Agro, Inc.  254 p.

 Beavers, J.; Sipler, O.; Jaber, M. (1992) Norflurazon Technical: A
 One-generation Reproduction Study with the Bobwhite (Colinus virginianus):
, Lab Project Number: 131-151. Unpublished study prepared by Wildlife
 International, Ltd. 164 p.

 Beavers, J.; Sipler, O.; Jaber, M. (1992) Norflurazon Technical: A
 One-generation Reproduction Study with the Mallard (Anas platyrhynchos): Lab
 Project Number: 131-152. Unpublished study prepared by Wildlife
 International, Ltd. 163 p.

 Guirguis, M. (1992) Magnitude of the Residues of Norflurazon and Desmethyl
 Norflurazon in Soybean Processed Fractions: Final Report: Lab Project Number
 Final Report: Lab Project Number: 234/91/1: 2341172A: 480488. Unpublished
 study prepared by JS.&D Sprayers, Inc., Texas A & M University and En-Cas
 Analytical Labs., Inc. 280 p.
                                        139

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                               BIBLIOGRAPHY
 MRID
                   CITATION
42663701
42710901
42754901
42764901
42880801
42880802
42909301
43041801
Guirguis, M. (1993) Magnitude of the Residues of Norflurazon and Desmethyl
Norflurazon in Grape Processed Fractions: Final Report: Lab Project Nos.:
232/91/1: 2321160A: 480488. Unpublished study prepared by Western
Agricultural Res., Viticulture & Enology Research Center and En-Cas Analytical
Labs., Inc. 294 p.

Skinner, W.; Dennis, P. (1993) Adsorption-Desorption of (Carbon 14)-
Norflurazon in Peat Soils: Final Laboratory Report:  Lab Project Number:
480485: DP-301164. Unpublished study prepared by Sandoz Agro, Inc. 70 p.

Hatfield, S. (1993) Validation for the Analytical Method: Determination of
Norflurazon and its Desmethyl Metabolite in Beef Liver, Muscle, and Fat
Tissues: Lab Project Number: AM-0875rl092-0: 9200539. Unpublished study
prepared by Harris Labs. 60 p.

Guirguis, M.; Rosas, M. (1993) Magnitude of the Residues of Norflurazon and
Desmethylnorflurazon in Citrus Processed Fractions: Laboratory Final Report:
Lab Proj Fractions: Laboratory Final Report: Lab Project Number: FEP
#231/91/1: 2311170B: 480488: QAU #91/04/11 A. Unpublished study prepared
by Univ. of Florida, CREC and EN-CAS Analytical Labs.,Inc. 276 p.

Guirguis, M. (1993) Field Accumulation of Norflurazon and its Desmethyl
Metabolite in Rotational Crops (CA): Lab Project Number: 2488168A: FEP
248/88/1: 480488. Unpublished study prepared by Pan-Agricultural
Laboratories, Inc.  532 p.

Rosas, M. (1993) Determination of the Stability of Residues of Norflurazon and
Desmethyl Norflurazon in Raw Agricultural Commodities: Laboratory Final
Report: Lab Project Number:480488: 13: DP 301322. Unpublished study
prepared by Sandoz Agro, Inc.  638 p.

Guirguis, M. (1993) Field Accumulation of Norflurazon and its Desmethyl
Metabolite in Rotational Crops (LA): Laboratory Final Report: Lab Project
Number: Report: Lab Project Number: 480488: DP-301295: 248/88/2.
Unpublished study prepared by Jensen Agricultural Consultants,Inc. and
Pan-Agricultural Labs, Inc. 567 p.

Skinner, W.; Dennis, P. (1993) Metabolites of [Pyridazinyl-14C]Norflurazon in
Peanuts, Cotton, and Citrus: Lab Project Number: 480485: 16: DP-301163.
Unpublished study prepared by Environmental Chemistry, Sandoz Agro, Inc.
116 p.
                                        140

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                                BIBLIOGRAPHY
 MRID
                    CITATION
43041802
43081501
43081502
43081503
43312501
4336690,1
43395801
43395802
43522301
 Graves, W.; Swigert, J. (1993) Norflurazon: A 96-Hour Shell Deposition Test
 with the Eastern Oyster (Crassostrea virginica): Lab Project Number:
 131A-156A. Unpublished study prepared by Wildlife International Ltd.  43 p.

 Sen, P.; Yu, C. (1993): Determination of a Sulfone Metabolite of Norflurazon in
 Rat Excreta: Final Report. Project No. 480485:19:301416. (Unpublished study
 prepared by Sandpz Agro, Inc.).

 Guirguis, A.; Yu, C. (1993) Norflurazon Metabolism in Lactating Goats Using
 Two Separate Labels (Phenyl Ring-UL-(carbon 14) and (4,5-(carbon
 14)-Pyridazinyl)): Final Report: Lab Project Number: 480485: 18: DP-301406.
 Unpublished study prepared by Sandoz Agro, Inc. 304 p.

 Nietschmann, D.; Ekdawi, M.; Yu, C. (1993)Norflurazon-Metabolism in Laying
 Hens Using (Phenyl-(carbon  14)) and Pyridazinyl-(carbon 14) Labels: Final
 Report: Lab Project Number: 480485: 15: DP/301350. Unpublished study
 prepared by Sandoz Agro, Inc. 147 p.

 Backus, P. (1994) Effect of Norflurazon on Seedling Emergence (Tier H):
 Supplemental Test: Lab Project Number: 93-0139:5745-93-0139-BE-001:
 5745-93-0139-BE-OOO. Unpublished study prepared by Ricerca, Inc. 92 p.

 O'Connell, T.; Arruda, J.; Belkind, B. (1994) Sensitivity of Technical
Norflurazon to Metals and Metal Ions: Final Report: Lab Project Number:
 480483: DP/301630. Unpublished study prepared by Sandoz Agro Analytical
 Chemistry Division. 55 p.                 \   .

 Guirguis, A.; Yu, C. (1994) Addendum to a Previous Report on Norflurazon  .
Metabolism in Lactating Goats Using Two Separate Labels (Phenyl
Ring-UL-(carbon 14)) and (4,5-(carbon 14)-Pyridazinyl): Lab Project Number:
480485: 18A: DP/301637. Unpublished study prepared by Sandoz Agro, Inc.
Metabolism/Pharmacokinetics Section. 51 p.

Nietschmann, D.A.; Yu, C. (1994) Addendum to a Previous Report on
Norflurazon Metabolism in Laying Hens Using [Phenyl-14C] and [Pyridazinyl-
 14C] Norflurazon Labels: Lab Project No. 480485: 15A: DP-301639.
Unpublished Study Prepared By Sandoz Agro, Inc. Metabolism/
Pharmacokinetics Section. 48 p.

Eschbach, B.; Aerni, R.; Herd, P.; et al. (1994): Two Generation Reproduction
 Study in Rats: Norflurazon: Revised Final Report. Project No.
440R.(Unpublished study prepared by Sandoz Agro, Ltd.).
                                        141

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                              BIBLIOGRAPHY
 MRID
CITATION
43 6723 01    Sandoz, Inc. (1995) Norflurazon Status of Analytical Enforcement Method for
            Plants. GDLN 171-4(c); DP Barcode: D216515. CBRS No. 15741.

43681001    Vollmin, s. (1995) 14C-DesmethylNorflurazon: Adsorption-Desorption (non-
            aged) by the Batch Equilibrium Method in Two Peat Soils.

43 859901    Rosas, M. (1995) Determination of the Stability of Norflurazon and its
            Desmethyl Metabolite in the Processed Fractions of Cotton Seed, Soybean,
            Grape, and Citrus Under Frozen Conditions: Final Report: Lab Project Number:
            480488: 20: 301822.  Unpublished study prepared by Sandoz Agro, Inc. 293 p.

GS0229-1    Confidential Statement of Formula (EPA Registration No. 11273-10).

GS0229-2    Sandoz-Wander Inc.  (1976) Correspondence in EPA Reg. No.  11273-10.

GS0229-3    SiHig, Marshall (ed.) (1977) Pesticide Process Encyclopedia, Noyes Data Corp.,
            Park Ridge, NJ.  p.351.

GS0299-4    Sandoz Inc.  (1983) Residues from Solicam applications to fruits and nuts prior
            to January 1978 (from CBK 3014/78001).  Supplement 3 to CBK 3080/83001.
            (Unpublished Summary submitted by Sandoz,  Inc. CDL:071403).
                                       142

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                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                     WASHINGTON, D.C. 20460
                                                                         OFFICE OF
                                                                   PREVENTION, PESTICIDES
                                                                   AND TOXIC SUBSTANCES
                       GENERIC AND PRODUCT SPECIFIC
                             DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:

      This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-in Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
produces) containing this active ingredient.  Within 90 days after you receive this Notice you
must respond as set forth in Section HI below. Your response must state:

      1.     How you will comply with the requirements set forth in this Notice and its
             Attachments 1 through 7; or
                                                                    i

      2.     Why you believe you are exempt from the requirements listed in this Notice and
             in Attachment 3 (for both generic and product specific data), the Requirements
             Status and  Registrant's Response Form, (see section ffi-B); or

      3.     Why you believe EPA should not require your submission of data in the manner
             specified by this Notice (see section EI-D).

      If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-in Response Forms.  Also included is a list of all
registrants who were sent this Notice (Attachment 6).

      The  authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
                                        143

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information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-96).

       This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-in Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I
Section n
Section ffl
Section IV
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Inquiries and Responses to this Notice
       The Attachments to this Notice are:

       1 -    Data Call-in Chemical Status Sheet
       2 -    Generic Data Call-in and Product Specific Data Call-in Response Forms with
             Instructions (Form A)
       3 -    Generic Data Call-in and Product Specific Data Call-in Requirements Status
             and Registrant's Response Forms with Instructions (Form B)
       4-    EPA Batching of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregistration
       5 -    List of Registrants Receiving This Notice
       6-    Confidential Statement of Formula, Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
revaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s).  You have been sent this Notice because
you have produces) containing the subject active ingredients.
SECTION H. DATA REQUIRED BY THIS NOTICE

H-A. DATA REQUIRED

      The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements).   Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
                                        144

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 n-B. SCHEDULE FOR SUBMISSION OF DATA

       You are required to submit the data or otherwise satisfy the data requirements specified
 in the Requirements Status and Registrant's Response Forms (Attachment 3) within the
 timeframes provided.

 n-C. TESTING PROTOCOL

       All studies required under this Notice must be conducted in accordance with test
 standards outlined in the Pesticide Assessment Guidelines for those studies for which
 guidelines have been established.

       These EPA Guidelines are available from the National Technical Information Service
 (NTIS), Attn: OrderDesk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
 703-487-4650).

       Protocols approved by the Organization for Economic Cooperation and Development
 (OECD) are also acceptable if the OECD recommended test standards conform to those
 specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
 OECD protocols, they should be modified as appropriate so that the data generated by the
 study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
 deadlines for complying with data requirements when the studies were not conducted in
 accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
 Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
 number 202-785-0350).

       All new studies and proposed protocols  submitted in response to  this Data Call-In
 Notice must be in accordance with Good Laboratory Practices [40 CFR  Part 160].
                                       '             N            '
 H-D.  REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
       BY THE AGENCY               :      '.           '.                  —	

       Unless otherwise noted herein, this Data Call-in does not in any way supersede or
. change the requirements of any previous Data Call-In(s), or any other agreements entered into
 with the Agency pertaining to such prior Notice. Registrants must comply with the
 requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
 products.


 SECTION m.     COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

       You must use the correct forms and instructions when completing your response to this
 Notice.  The type of Data Call-in you must comply with (Generic or Product Specific) is
 specified in item number 3 on the four Data Call-In forms (Attachments  2 and 3).
                                        145

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IH-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

       The appropriate responses initially required by this Notice for generic and product  .
specific data must be submitted to the Agency .within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a Notice of latent to Suspend (NOIS)  affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.                                                ,

m-B.  OPTIONS  FOR RESPONDING TO THE AGENCY

       1, Generic Data Requirements

       The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver(s).

       A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying  the generic data requirements of this Notice is
contained in Section IH-C. A^discussion of options relating to requests for data waivers is
contained in Section m-D.

       Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response.  These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments 2 and 3, respectively).

       The Data Call-in Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be  submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration(s). Please note that the company's authorized representative is required to
sign the first page  of both Data Call-in Response Forms and the Requirements Status and
Registrant's Response Forms (if this form is required) and initial any subsequent pages. The
forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment 1.

       a.     Voluntary Cancellation -

       You may avoid the requirements of this Notice by requesting voluntary cancellation of
your produces) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must  submit completed Generic and Product Specific
Data Call-in Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item  number 5 on both  Data Call-In Response Form(s). If you
choose this option, these are the only forms that you are required to complete.

                                         146

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        If you chose to voluntarily cancel your product, further sale and distribution of your
. product after the effective date of cancellation must be in accordance with the Existing Stocks
 provisions of this Notice, which are contained in Section IV-C.

        b.     Use Deletion -

        You may avoid the requirements of this Notice by eliminating the uses of your product
 to which the requirements apply. If you wish to amend your registration to delete uses, you
 must submit the Requirements Status and Registrant's Response Form (Attachment 3)/a
 completed application for amendment, a copy of your proposed amended labeling, and all
 other information required for processing the application.  Use deletion is option number 7
 under item 9  in the instructions for the Requirements Status and Registrant's Response Forms.
 You must also complete a Data Gall-In Response Form by signing the certification, item
 number 8.  Application forms for amending registrations may be obtained from the
 Registration Support Branch, Registration Division,  Office of Pesticide Programs, EPA  bv
 calling (703)  308-8358.

        If you choose to delete the use(s) subject to this Notice or uses subject to  specific data
 requirements, further sale, distribution, or use of your product after one year from the due
 date of your 90 day response, is allowed only if the product bears an 'amended label.

        c.     Generic Data Exemption -

        Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
 exempt from the requirement to submit or cite generic data concerning an active ingredient if
 the active ingredient in the product is derived exclusively from purchased, registered pesticide
 products containing the active ingredient. EPA has concluded, as an exercise of its discretion,
 that it normally will not suspend the registration of a product which would qualify and
 continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,
 a]l of the following requirements must be met:

        (i).  The active ingredient in your registered product must be present solely because of
        incorporation of another registered product which contains the subject active ingredient
        and is  purchased from a source not connected with you;


        (ii).  Every registrant who is the ultimate source of the active ingredient in your
       product subject to this DCI must be in compliance with the requirements of this Notice
       and must remain in compliance; and

       (iii). You must have provided to  EPA an accurate and current "Confidential Statement
       of Formula" for each of your products to which this Notice applies.

       To apply for the Generic Data Exemption you must submit a completed Data Call-in
 Response Form, Attachment 2 and all supporting documentation.  The Generic Data Exemption
 is item number 6a on the Data Call-In Response  Form.  If you claim a generic data exemption

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you are not required to complete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option for responding to product specific
data requirements.

       If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrants) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or are
no longer in compliance with this Data Call-in Notice, the Agency will consider that both they
and you are not compliance and will normally initiate proceedings to suspend the registrations
of both your and their produces), unless you commit to submit and do submit the required
data within the specified time. In such cases the Agency generally will not grant a time
extension for submitting the data.

       d.     Satisfying the Generic Data Requirements of this  Notice

       There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section DI-C.L of this Notice and comprise options 1
through 6. of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-in Response Form. If you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement.  Your response must be on the
forms marked "GENERIC" in item number 3.             :

       e.     Request for Generic Data Waivers.

       Waivers for generic data are discussed in Section ni-D.l. of this Notice and are
covered by options 8  and 9 of item 9 in the  instructions for the Requirements Status and
Registrant's Response Form. If you choose  one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.

       2. Product Specific Data Requirements

       The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice
or (c) request a data waiver(s).

       A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below.  A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section IH-C.2. A discussion of
options relating to requests for data waivers is contained in Section m-D.2.

       Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-CaU-In Response Form, and the Requirements Status and Registrant's Response Form,

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 for product specific data (contained in Attachments 2 and 3, respectively). The Data Call-In
 Response Form must be submitted as part of every response to this Notice.  In addition, one
 copy of the Requirements Status and Registrant's Response Form also must be submitted for
 each product listed on the Data Call-In Response Form unless the voluntary cancellation option
 is selected.  Please note that the company's authorized representative is required to sign the
 first page of the Data Call-In Response Form and Requirements Status and Registrant's
 Response Form (if this form is required) and initial any subsequent pages. The forms contain
 separate detailed instructions  on the response options.  Do not alter the printed material. If you
 have questions or need assistance in preparing your response, call or write the contact
 person(s) identified in Attachment 1.                       '     ,  -

       a.     Voluntary Cancellation

       You may avoid the requirements of this Notice by requesting voluntary cancellation of
 your product(s) containing the active ingredient that is the subject of this Notice. If you wish
 to voluntarily cancel your product, you must submit a completed Data Call-In Response Form,
 indicating your election of this option. Voluntary cancellation is item number 5 on both the
 Generic and Product Specific Data Call-in Response Forms. If you choose this
 option, you must complete both Data Call-In response forms.  These are the only forms that
 you are required to complete.

       If you choose to voluntarily cancel your product, further sale and distribution of your
 product after the effective date of cancellation must be in accordance with the Existing  Stocks
 provisions of this Notice which are contained in Section IV-C.

       b.     Satisfying the Product Specific Data Requirements of this Notice.

       There are various options available to satisfy the product specific data requirements of
 this Notice, These  options are discussed in Section IH-C.2. of this Notice and comprise
 options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
 and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product
 specific data requirements for an MUP or EUP as applicable) on the product specific Data
 Call-in Response Form. Note that the options available for addressing product specific  data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.  It is important to ensure that you are using the correct
forms and instructions when completing  your response to the Reregistration Eligibility
Decision document.

       c.     Request for Product Specific Data Waivers.

       Waivers for product"specific data are discussed in Section m-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements  Status and
Registrant's Response Form.  If you choose this option, you must submit the Data Call-in
Response Form and the Requirements Status and Registrant's Response Form as well as any
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other information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.

m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
       1.
Generic Data
       If you acknowledge on the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed^
immediately below with information hi parentheses to guide you to additional instructions
provided in this Section.  The options are:

       (1)    I will generate and submit data within the specified timeframe (Developing
             Data)
       (2)    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
       (3)    I have made offers to cost-share (Offers to Cost Share)
       (4)    I am submitting an existing study that has not been submitted previously to the
             Agency by anyone (Submitting an Existing Study)
       (5)    I am submitting or citing data to upgrade a study classified by EPA as partially
             acceptable and upgradeable (Upgrading a Study)
       (6)    I am citing an existing study that EPA has classified as acceptable or an existing
             study that  has been submitted but not reviewed by the Agency (Citing an
             Existing Study)

Option 1. Developing Data

       If you choose to develop the required data it must be in conformance with Agency
deadlines and with other  Agency requirements as referenced herein and in the attachments. All
data generated and submitted must comply with the Good Laboratory Practice (GLP) rule  (40
CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be
in conformance with the  requirements  of PR  Notice 86-5. In addition, certain studies require
Agency approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been  identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wish to use a protocol which differs from
the options discussed in Section IE-C of this Notice, you must submit a detailed description of
the proposed protocol and your reason for wishing to use it. The Agency may choose to reject
a protocol not specified in Section n-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission  of data.
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       A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study.  This 90-day progress report must include the date the study was or will
be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study.

       In  addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals  from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the other
information  specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.

       The time frames in the Requirements Status and Registrant's Response Form are the
time frames  that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of .a Notice oif
Intent to Suspend the affected registratibn(s).

       If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed  description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains.  The Agency will respond to your request in writing.  If EPA does
not grant your request, the original deadline remains.  Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is  submitted at or after the lapse of the subject
deadline.                                             '   •        '.      /    .  '

Option 2.  Agreement to Share in Cost to Develop Data

       If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be  submitting the data. You must also provide  EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your  offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
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 Option 3. Offer to Share in the Cost of Data Development

       If you have made an offer to pay in an attempt to enter into an agreement or amend an
 existing agreement to meet the requirements of this Notice and have been unsuccessful, you
 may request EPA (by selecting this option) to exercise its discretion not to suspend your
 registration(s), although you do not comply with the data submission requirements of this
 Notice. EPA has determined that as a general policy, absent other relevant considerations, it
 will not suspend the registration of a product of a registrant who has in good faith sought and
 continues to seek to enter into a joint data development/cost sharing program, but the other
 registrant(s) developing the data has refused to accept the offer.  To qualify for this option, you
 must submit documentation to the Agency proving that you have made an offer to another
 registrant (who has an obligation to submit data) to share in the burden of developing that
 data. You must also submit to the Agency a completed EPA Form 8570-32,  Certification of
 Offer to Cost Share in the Development of Data, Attachment 7.  In addition, you must
 demonstrate that the other registrant to whom the offer was made has not accepted your offer
 to enter into a cost-sharing agreement by including a copy of your offer and  proof of the other
 registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
 to anything else, offer to  share in the burden of producing the data upon terms to be agreed to
 or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its
 election of an option to develop and submit the data required by this Notice by submitting a
 Data Call-in Response Form and a Requirements Status and Registrant's  Response Form
 committing to develop and submit the data required by this Notice.

       In order for you to avoid suspension under this option, you may not withdraw your
 offer to share in the burden of developing the data. In addition, the other registrant must fulfill
 its commitment to develop and submit the data as required by this Notice. If the other
 registrant fails to develop the data or for some other reason is subject to suspension, your
 registration as well as that of the  other registrant normally will be subject to  initiation of
 suspension proceedings, unless you commit to  submit, and do submit, the required data in the
 specified time frame. In such cases, the Agency generally will not grant a time extension for
 submitting the data.

 Option 4. Submitting an Existing Study

       If you choose to submit an existing study in response to this Notice, you must
 determine that the study satisfies the requirements imposed by this Notice. You may only
 submit a study that has not been previously submitted to the Agency or previously cited by
 anyone. Existing studies are studies which predate issuance of this Notice/Do not use this
 option if you are submitting data to upgrade a study. (See Option 5).

       You should be  aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
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       To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met;                                      	
       a.
              You must certify at the time that the existing study is submitted that the raw
              data and specimens from the study are available for audit and review and you
              must identify where they are available. This must be done in accordance ,with
              the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
              Part 160. As stated in 40 CFR 160.3 'Raw data'  means any laboratory
              worksheets, records,  memoranda, notes, or exact copies thereof, that are the
              result of original observations and activities of a study and are necessary for the
              reconstruction and evaluation of the report of that study. In the event that exact
              transcripts of raw data have been prepared (e.g., tapes which have been
              transcribed verbatim, dated, and verified accurate by signature), the exact copy
              or exact transcript may be substituted for the original source as raw data. 'Raw
              data1 may include photographs, microfilm or microfiche copies, computer
              printouts, magnetic media, including dictated observations, and recorded data
              from automated instruments." The term "specimens", according to 40 CFR
              160.3, means "any material derived from a test system for examination or
              'analysis."

       b.     Health and safety studies completed after May 1984 also must also contain all
              GLP-required quality assurance and quality control information, pursuant to the
              requirements of 40 CFR Part 160. Registrants also must certify at the time of
              submitting the existing study that such GLP information is available for post
              May 1984 studies by including an appropriate statement on or attached to the
              study signed by  an authorized official or representative of the registrant.

       c.     You must certify that each study fulfills the acceptance criteria for the Guideline
              relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
              Technical Guidance and that the study has  been conducted according to the
              Pesticide Assessment  Guidelines (PAG) or meets  the purpose of the PAG (both
              available from NTIS). A study not conducted according to the PAG may be
              submitted to the Agency for consideration if the registrant believes  that the
              study clearly meets the purpose of the PAG. The  registrant is referred to 40
              CFR 158.70 which states the Agency's policy regarding acceptable protocols. If
              you wish to submit the study, you must, in addition to certifying that the
              purposes of the PAG are met by the study, clearly articulate  the rationale why  ,
              you believe the study  meets the purpose of the PAG, including copies of any
              supporting information or data. It has been the Agency's experience that studies
              completed prior  to January  1970 rarely satisfied the purpose  of the  PAG and
              that necessary raw data usually are not available for such studies.

       If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
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       If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.

       If you know  of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.

Option 5. Upgrading a Study

       If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies  will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded,, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.

       Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.

       This option also should be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.

       The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria, as  well as a certification regarding protocol compliance with Agency
requirements.

Option 6. Citing Existing Studies

       If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the

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  classification generally would be a rating of "core." For all other disciplines the classification
  would be "acceptable." With respect to any studies for which you wish to select this option,
  you must provide the MRID number of the study you are citing and, if the study has been '
  reviewed by the Agency, you must provide the Agency's classification of the study.

        If you are citing a study of which you are not the original data submitter, you must
  submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
  Compensation Requirements.

        2. Product Specific Data

        If you acknowledge on the product specific Data Call-In Response Form that you agree
  to satisfy the product specific data requirements (i.e. you select option 7a or 7b), then you
  must select one of the six options on the Requirements Status and Registrant's Response Form
  related to data production for each data requirement. Your option selection should be entered
  under item number 9, "Registrant Response." The six options related to data production are
  the first six options discussed under item 9 in the instructions for completing the Requirements
  Status and Registrant's Response Form. These six options are listed immediately below with
  information in parentheses to guide registrants to additional instructions provided in this.
  Section. The options are:

        (1)  .1 will generate and submit data within the specified time-frame (Developing
              Data)
        (2)   I have entered into an agreement with one or more registrants to develop data
              jointly (Cost Sharing)
        (3)   I have made offers to cost-share (Offers to Cost Share)
        (4)   I am submitting an existing study that has not been submitted previously to  the
              Agency by anyone (Submitting an Existing Study)
        (5)    I am submitting or citing data to upgrade a study classified by EPA as partially
              acceptable and upgradeable (Upgrading a Study)
        (6)    I am citing an existing study that EPA has classified as acceptable or an existing
              study that has been
              submitted but not reviewed by the Agency (Citing an Existing Study)

 Option 1.  Developing Data — The requirements for developing product specific data are the
'same as those described for generic data (see Section m.C.l, Option 1) except that normally
 no protocols or progress reports are required.

 Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost
 share, the same requirements apply to product specific data as to generic data  (see Sectipn
 in.C.I, Option 2). However, registrants may only choose this option for acute toxicity data
 and certain efficacy data and only if EPA has indicated in the attached data tables that your
 product and at least one other product are similar for purposes of depending on
 the same data. If this is the case, data may be generated for just one of the products "in the
 group.  The registration number of the product for which data will be submitted must be noted
«in the agreement to cost share by the  registrant selecting this option.

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Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section m.C.L, Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.

Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section m.C.L, Option 4) apply to this option for product specific data.

Option 5. Upgrading a Study — The same requirements described for generic data (see Section
EH.C. 1., Option 5) apply to this option for product specific data.

Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section ffi.C.l., Option 6) apply to this option for product specific data.

       Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (m.C.l.), as appropriate.
ffl-D REQUESTS FOR DATA WAIVERS
       1.
Generic Data
       There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirements) are not appropriate for your product.

       a.     Low Volume/Minor Use Waiver

             Option 8 under item 9 on the Requirements Status and Registrant's Response
       Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness  of
       requiring data for low volume,  minor use pesticides. In implementing this provision,
       EPA considers low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to grant a low
volume, minor use waiver, the Agency will consider the extent, pattern and volume of use, the
economic incentive to conduct the testing, the importance of the pesticide, and the exposure
and risk from use of the pesticide. If an active ingredient is used for both high volume and low
volume uses, a low volume exemption will not be approved. If all uses of an active ingredient
are low volume and the combined volumes for all uses are  also low, then an exemption may be
granted, depending on review of other information outlined below. An exemption will not be
granted if any registrant of the active ingredient elects to conduct the testing. Any registrant
receiving a low volume minor use waiver must remain within the sales figures in their forecast
supporting the waiver request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual sales
reports. The Agency will respond to requests for waivers in writing.
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                                   ' '             • •               *
        To apply for a low volume, minor use waiver, you must submit the following
 information, as applicable to your product(s), -as part of your 90-day response to this
 Notice:

        (i).  Total company sales (pounds and dollars) of all registered product(s)
 containing the active ingredient. If applicable to the active ingredient,  include foreign
 sales for those products that are not registered in this country but are applied to sugar
 (cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
 information by year for each of the past five years.

        (ii)  Provide an estimate of the sales (pounds and dollars) of the active
 ingredient for each major use site. Present the above information by year for each of
• the past five years'.

        (iii) Total direct production cost of product(s) containing the active ingredient
 by year for the past five years. Include information on raw material  cost, direct labor
 cost, advertising, sales and marketing, and any other significant costs listed separately.

        (iv) Total indirect production cost (e.g. plant overhead, amortized  plant and
 equipment) charged to produces) containing the active ingredient by year for the past
 five years. Exclude all non-recurring costs that were directly related to the active
 ingredient, such as costs of initial registration and any data development.

        (v) A list of each data requirement for which you seek a waiver. Indicate the
 type of waiver sought and the estimated cost to you (listed separately for each data ,
 requirement and associated test) of conducting the testing needed to fulfill each of these
 data requirements.

        (vi) A list of each data requirement for which you are not seeking any waiver
 and the estimated cost to you (listed  separately for each data requirement and associated
 test) of conducting the testing needed to fulfill each of these data requirements.

        (vii)  For each of the next ten years, a year-by-year forecast of company sales
 (pounds and dollars) of the active ingredient, direct production costs of produces)
 containing the active ingredient  (following the parameters in item 2 above), indirect
 production costs of product(s) containing the active ingredient (following the
 parameters in item 3 above), and costs of data development pertaining  to the active
 ingredient.

       (viii) A description of the importance and unique benefits of the active
 ingredient to users. Discuss the use patterns and the effectiveness  of the active
 ingredient relative to registered alternative chemicals and non-chemical control
 strategies. Focus on benefits unique to the active ingredient, providing  information that
 is as quantitative as possible. If you do not have quantitative data upon which to base
 your estimates, then present the  reasoning used to derive your estimates. To assist the
 Agency in determining the degree of importance of the active ingredient in terms of its

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benefits, you should provide information on any of the following factors, as applicable
to your produces): (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient after use and on its
persistence in the environment, and (d) description of its  usefulness against a pest(s) of
public health significance.

       Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the
request for a waiver.

b.     Request for Waiver of Data

       Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe mat a particular data requirement should ,
not apply because the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements  should not apply. You also must
submit the current label(s) of your produces) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.

       You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements  of this Notice are not appropriate to your
produces), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines  that the data are required for your product(s), you must choose a
method of meeting the requirements of this Notice within the time frame provided by
this Notice. Within 30 days  of your receipt of the Agency's  written decision, you must
submit a revised  Requirements  Status  and Registrant's Response Form indicating the
option chosen;

2. Product Specific Data

       If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies.  (Note: any supplemental data must be submitted in the format required by  PR
Notice 86-5). This will be the only opportunity to  state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must  choose an option for meeting the  data
requirements of this Notice within 30  days of the receipt  of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements for product
chemistry,  acute  toxicity and efficacy (where appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You

                                   158

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       should also be aware that submitting a waiver request will not automatically extend the
       due date for the study in question. Waiver requests submitted without adequate
       supporting rationale will be denied and the original due date will remain in force.
SECTION IV.
       CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
       NOTICE            ~        ~~
IV-A  NOTICE OF INTENT TO SUSPEND

       The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant
to FIFRA section 3(c)(2)(B). Events which may be the'basis for issuance^of a Notice of Intent
to Suspend include, but are not limited to, the following:
       1.


       2.


       3.
      7.

      8.
Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.

Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.

Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice. ,

Failure to submit on the required schedule acceptable data as required by this
Notice.

Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).

Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section m-C of this Notice.

Withdrawal of an offer to share in the cost of developing required data.

Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer
or failure of a registrant on whom you rely for  a generic data exemption either
to:
                                         159

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             i.  Inform EPA of intent to develop and submit the data required by this Notice
             on a Data Call-in Response Form and a Requirements Status and Registrant's
             Response Form.

             ii. Fulfill the commitment to develop and submit the data as required by this
             Notice; or

             Mi.  Otherwise take appropriate steps to meet the requirements stated in this
             Notice,                                     .

             unless you commit to submit and do submit the required data in the specified
             time frame.

       9.     Failure to take any required or appropriate steps, not mentioned above, at any
             time following the issuance of this Notice.

IV-B.  BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
       UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:

       1)     EPA requirements specified in the Data Call-in Notice or other documents
       incorporated by reference (including, as applicable, EPA  Pesticide Assessment
       Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
       regarding the design, conduct, and reporting  of required studies. Such requirements
       include, but are not limited to, those relating to test material, test procedures, selection
       of species, number of animals, sex and distribution of animals, dose and effect levels to
       ,be tested or attained, duration of test, and, as applicable,  Good Laboratory Practices.

       2)     EPA requirements regarding the submission of protocols, including the
       incorporation of any changes required by the Agency following review.

       3)     EPA requirements regarding the reporting of data, including the manner of
       reporting, the completeness of results, and the adequacy of any required supporting (or
       raw) data, including, but not limited to, requirements referenced or included in this
       Notice or contained in PR 86-5. All studies must be submitted in the form of a final
       report; a preliminary report will not be considered to fulfill the submission
       requirement.

IV-C  EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

       EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.

                                        160

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       The Agency has determined that such disposition by registrants of existing stocks for a
 suspended registration when a section 3(c)(2)(B) data request is outstanding generally would
 not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
 registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
 exceptional circumstances. If you believe such disposition of existing stocks of your produces)
 which may be suspended for failure to comply with this Notice should be permitted, you have,
 the burden of clearly demonstrating to EPA that granting such permission would be consistent
 with the Act. You also must explain why an "existing stocks" provision is necessary, including
 a statement of the quantity of existing stocks and your estimate of the time required for their
 sale, distribution, and use. Unless you meet this burden, the Agency will not consider any
 request pertaining to the continued sale, distribution, or use of your existing stocks after
 suspension.     ,

       If you request a voluntary cancellation of your produces) as a response to this Notice
 and your product is in full compliance with all Agency requirements, you will have, under
 most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
 distribute, or use existing stocks. Normally, the Agency will allow persons other than the
 registrant such as independent distributors, retailers and end users to sell, distribute or use
 such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
 voluntarily cancelled products containing an active ingredient for which the Agency has
 particular risk concerns  will be determined on a case-by-case basis:

       Requests for voluntary cancellation received after the 90 day response period required
 by this Notice will not result in the agency granting any additional time to sell, distribute, or
 use existing stocks beyond a year from the date the 90 day response was due, unless you
 demonstrate to the Agency that you are in full compliance with all Agency requirements,
 including the requirements of this Notice. For example, if you decide to voluntarily cancel
 your registration six months before a  3-year study is scheduled to be submitted, all progress
 reports and other information necessary to establish that you have been conducting the study in
 an acceptable and good faith manner must have been submitted to the Agency, before EPA
 will consider  granting an existing stocks provision.
SECTION V.
REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
       Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
                                         161

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SECTION VI.
             INQUIRIES AND RESPONSES TO THIS NOTICE
      If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-in Chemical Status
Sheet.

      All responses to this Notice must include completed Data Call-in Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and product specific data) and any other documents required
by this Notice, and should be submitted to the contact person(s) identified in Attachment 1.  If
the voluntary cancellation or generic data exemption option is chosen, only the Generic and
Product Specific Data Call-in Response Forms need be submitted.

      The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.

                                Sincerely yours,
                                Lois Rossi, Division Director
                                Special Review and
                                 Reregistration Division
Attachments
      The Attachments to this Notice are:

      1 -    Data Call-In Chemical Status Sheet
      2 -    Generic Data Call-in and Product Specific Data Call-in Response Forms with
             Instructions
             Generic Data Call-in and Product Specific Data Call-in Requirements Status
             and Registrant's Response Forms with Instructions
             EPA Batching of End-Use Products for Meeting Acute Toxicology Data
3-

4-

5-
6-
             Requirements for Reregistration
             List of Registrants Receiving This Notice
             Confidential Statement of Formula, Cost Share and Data Compensation Forms
                                      '  162

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NORFLURAZON DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION                                                    .

       You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing norflurazon.

       This Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
norflurazon. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-in Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) a list of
registrants receiving this DCI (Attachment 5) and (6) the Cost Share and Data Compensation
Forms in replying to this norflurazon Product Specific Data Call-in (Attachment 6).
Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the database for norflurazon are
contained in the Requirements Status and Registrant's Response, Attachment 3.  The Agency
has concluded that additional data on norflurazon are needed for specific products. These data
are required to be submitted to the Agency within the time frame listed.  These data are
needed to fully complete the reregistration of all eligible Norflurazon products.

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Veronica Dutch at (703) 308-8585.

      All responses to this Notice for the Product Specific data requirements should be
      submitted to:
             Veronica Dutch  ...",.
             Chemical Review Manager Team 81
             Product Reregistration Branch
             Special Review and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S.  Environmental Protection Agency
             Washington, D.C. 20460

             RE: NORFLURAZON
                                        163

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NORFLURAZON DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION                            ,

      You have been sent this Generic Data Call-in Notice because you have product(s)
containing norflurazon.

      This Generic Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
norflurazon. This attachment is to be used in conjunction with (1) the Generic Data Call-in
Notice, (2) the Generic Data Call-in Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 3), (4) a list of registrants receiving this DCI
(Attachment 4), and (5) the Cost Share and Data Compensation Forms hi replying to this
norflurazon Generic Data Call In (Appendix D). Instructions and guidance accompany each
form.

DATA REQUIRED BY THIS NOTICE
      The additional data requirements needed to complete the generic database for
norflurazon are contained in the Requirements Status and Registrant's Response, Attachment
3. The Agency has concluded that additional product chemistry, acute toxicity, residue
chemistry, environmental fate, and plant protection data on norflurazon  are needed.  These
data are needed to fully complete the reregistration of all eligible norflurazon products.

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Karen Jones at (703) 308-8047.

      All responsades to this Notice for the generic data requirements should be submitted to:

             Karen Jones, Chemical Review Manager
             Reregistration Branch
             Special Review and Registration Division (H7508W)
             Office of Pesticiafde Programs
             U.S.  Environmental Protection Agency
             Washington, D.C.  20460
             RE:  NORFLURAZON
                                        164

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  Instructions For Completing The "Data Call-In Response Forms" For The Generic And
                             Product Specific Data Call-in
INTRODUCTION

       These instructions apply to the Generic and Product Specific "Data Call-in Response
Forms" and are to be used by registrants to respond to generic and product specific Data
Call-ins as part of EPA's Reregistration Program under the Federal Insecticide, Fungicide,
and Rodenticide Act.  If you are an end-use product registrant only and have been sent this
DCI letter as part of a RED document you have been sent just the product specific "Data
Call-in Response Forms." Only registrants responsible for generic data have been sent the  ;
generic data response form. The type of Data Call-in (generic or product specific) is
indicated in item number 3 ("Date and Type of DCI") on each form.


       Although the form is the same for both generic and product specific data, instructions
for completing these forms are different.  Please read these instructions carefully before filling
out the forms.     '

       EPA has developed these forms individually for _each registrant, and has preprinted   ,
these forms with a number of items.  DO  NOT use these forms for any other active
ingredient.

       Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be
completed by the registrant as appropriate. Items 8 through 11 must be completed by the
registrant before submitting a response to  the Agency.

       The public reporting burden for this collection of information is estimated  to average
15 minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information.  Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and  to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107,  Washington, D.C. 20503.
                                         165

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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item 1.       ON BOTH FORMS: This item identifies your company name, number and
             address.

Item 2;       ON BOTH FORMS: This item identifies the case number, case name, EPA
             chemical number and chemical name.

ItemS.       ON BOTH FORMS: This item identifies the type of Data Call-In.  The date
             of issuance is date stamped.
                                               - ,        •         .    t      ' •  *   '  i
Item 4.       ON BOTH FORMS: This item identifies the EPA product registrations
             relevant to the data call-in.  Please note that you are also responsible for
             informing the Agency of your response regarding any product that you believe
             may be covered by this Data Call-in but that is not listed by the Agency in Item
             4. You must bring any such apparent omission to the Agency's attention within
             the period required for submission of this response form.

Item 5.       ON BOTH FORMS: Check this item for each product registration you wish to
             cancel voluntarily. If a registration number is listed for a product for which you
             previously requested voluntary cancellation, indicate in Item 5 the date of that
             request. Since this Data Call-in requires both generic and product specific data,
             you must complete item 5 on both Data Call-In response forms. You do not
             need to complete  any item on the Requirements Status and Registrant's
             Response Forms.

Item 6a.      ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is for
             generic data as indicated in Item 3 and you are eligible for a Generic Data
             Exemption for the chemical listed in Item 2 and used in the subject product.  By
             electing this exemption, you agree to the terms and conditions of a Generic Data
             Exemption as explained in the Data Call-in Notice.

             If you are eligible for or claim a Generic Data Exemption, enter the EPA
             registration Number of each registered source of that active ingredient that you
             use in your product.

             Typically, if you purchase an EPA-registered product from one or more other
             producers (who, with respect to the incorporated product, are in compliance
             with this and any  other outstanding Data Call-in Notice), and incorporate that
             product into all your products,  you may complete this item for  all products
             listed on this form. If, however, you produce the active ingredient yourself, or
             use any unregistered product (regardless of the fact that some of your sources .
                                        166

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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In           '

             are registered), you may not claim a Generic Data Exemption and you may not
             select this item!          ,

Item 6b.      ON THE GENERIC DATA FORM:  Check this Item if the Data Call-In is for
             generic data as indicated in Item 3 and if you are agreeing to satisfy the generic
             data requirements of this Data Call-in. Attach the Requirements Status and
             Registrant's Response Form that indicates how you will satisfy those
             requirements.

             NOTE: Item 6a and 6b are not applicable for Product Specific Data.

Item 7a.      ON THE PRODUCT SPECIFIC DATA FORM:  For each manufacturing use
             product (MUP) for which you wish to maintain registration, you must agree to
             satisfy the data requirements  by responding "yes."

Item 7b.      For each end use product (EUP) for which you wish to maintain registration,
             you must agree to satisfy the data requirements by responding  "yes."

             FOR BOTH MUP and EUP products

             You should also respond "yes"  to this item (7a for MUP's and 7b for EUP's) if
             your product is identical to another product and you qualify for a data
             exemption.  You must provide the EPA registration numbers of your source(s);
             do not complete the Requirements Status and Registrant's Response form.
             Examples of such products include repackaged products and Special Local
             Needs (Section 24c) products which are identical to federally registered
             products.

             If you are requesting a data waiver, answer "yes" here; in addition, on the
             "Requirements Status and Registrant's Response" form under Item 9, you must
             respond with option 7 (Waiver Request) for each study for which you are
             requesting a waiver.

             NOTE: Item 7a and 7b are not applicable for  Generic Data.
                                       167

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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 8.       ON BOTH FORMS:  This certification statement must be signed by an
              authorized representative of your company and the person signing must include
              his/her title. Additional pages used hi your response must be initialled and
              dated in the space provided for the certification.

Item 9.       ON BOTH FORMS:  Enter the date of signature.

Item 10.      ON BOTH FORMS:  Enter the name of the person EPA should contact with
              questions regarding your response.

Item 11.      ON BOTH FORMS:  Enter the phone number of your company contact.
 Note:    You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you
        may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
        product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct
                                          168

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    Instructions For Completing The "Requirements Status and Registrant's Response
               Forms" For The Generic and Product Specific Data Call-In


INTRODUCTION

       These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specific Data Call-in's as part of,EPA's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act.  If you are an end-use product registrant only
and have been sent this DCI letter as part of a RED document you have been sent just the
product specific "Requirements Status and  Registrant's Response Forms."  Only registrants
responsible for generic data have been sent the generic data response forms.  The type of
Data Call-in (generic or product specific) is indicated in item number 3 ("Date and Type
of DCI") on each form.

       Although the form is the same for both product specific and generic data, instructions
for completing the forms differ slightly.  Specifically, options for satisfying product .specific
data requirements do not include (1) deletion of uses or (2) request for a low volume/minor
use waiver. Please read these instructions  carefully before rilling out the forms.

       EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information unique to this chemical. DO NOT use these forms
for any other active ingredient.

       Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.

       The public reporting burden for this collection of information is estimated to average
30 minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of.
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington,  D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
                                         169

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    INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                      REGISTRANT'S RESPONSE FORMS"

Generic and Product Specific Data Call-in
Item 1.       ON BOTH FORMS:  This item identifies your company name, number and
             address.

Item 2.       ON THE GENERIC DATA FORM: This item identifies the case number,
             case name, EPA chemical number and chemical name,

             ON THE PRODUCT SPECIFIC DATA FORM:  This item identifies the
             case number, case name, and the EPA Registration Number of the product for
             which the Agency is requesting product specific data.

ItemS.       ON THE GENERIC DATA FORM: This item identifies the type of Data
           * Call-In. The date of issuance is date stamped.   ,

             ON THE PRODUCT SPECIFIC DATA FORM:  This item identifies the type
             of Data Call-in.  The date of issuance is also date stamped.  Note the unique
             identifier number (ID#) assigned by the Agency. This ID number must be used
             in the transmittal document for any data submissions in response to this Data
             Call-In Notice.

Item 4.       ON BOTH FORMS:  This item identifies the guideline reference number of
             studies required. These guidelines, in addition to the requirements specified in
             the Data Call-in Notice, govern the conduct of the required studies. Note that
             series 61 and 62 in product chemistry are now listed under 40 CFR 158.155
             through 158.180, Subpart c.

Item5.       ON BOTH FORMS:  This item identifies the study tide associated with the
             guideline reference number and whether protocols and 1, 2, or 3-year progress
             reports are required to be submitted in connection with the study.  As noted in
             Section HE of the Data Call-In Notice, 90-day progress reports are required for
             all studies.

             If an asterisk appears in Item 5, EPA has attached information relevant to this
             guideline reference number to the Requirements Status and Registrant's
             Response Form.
                                      170

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    INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                      REGISTRANT'S RESPONSE FORMS"

Generic and Product Specific Data Call-In

Item 6.       ON BOTH FORMS: This item identifies the code associated with the use
             pattern of the pesticide.  In the case of efficacy data (product specific
             requirement), the required study only pertains to products which have the use
             sites and/or pests indicated.  A brief description of each code follows:

             A    Terrestrial food
             B    Terrestrial feed
             C    Terrestrial non-food
             D    Aquatic food
             E    Aquatic non-food outdoor
             F    Aquatic non-food industrial
             G    Aquatic non-food residential
             H    Greenhouse food
             I     Greenhouse non-food crop
             J     Forestry
             K    Residential
             L    Indoor food
             M    Indoor non-food
             N   . Indoor medical
             O    Indoor residential

Item 7.       ON BOTH FORMS: This item identifies the code assigned to the substance
             that must be used for testing. A.brief description of each code follows:
            EUP
            MP
            MP/TGAI

            PAI
            PAI/M
            PAI/PAIRA

            PAIRA
            PAIRA/M
            PAIRA/PM

            TEP
            TEP    %
            TEP/MET
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical GradeActive
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product .
Typical End-Use Product, Percent Active Ingredient
Specified                                 v
Typical End-Use Product and Metabolites
                                       171

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             TEP/PAI/M

             TGAI
             TGAI/PAI

             TGAI/PAIRA

             TGAI/TEP

             MET
             IMP
             DEGR  '
             *
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
Degradates
See: guideline comment
Item 8.       This item completed by the Agency identifies the time frame allowed for
             submission of the study or protocol identified in item 5.

             ON THE GENERIC DATA FORM:  The time frame runs from the date of
             your receipt of the Data Gall-In notice.

             ON THE PRODUCT SPECIFIC DATA FORM:  The due date for
             submission of product specific studies begins from the date stamped on the letter
             transmitting the Reregistration Eligibility Decision document, and not from the
             date of receipt. However, your response to the Data Call-In itself is due 90
             days from the date of receipt.                                           ,

Item 9.       ON BOTH FORMS:  Enter the appropriate Response Code or Codes to show
             how you intend to comply with each data requirement. Brief descriptions of
             each code follow. The Data Call-in Notice contains  a fuller description of each
             of these options.

      Option 1.    ON BOTH FORMS:  (Developing Data) I will conduct a new study and
                   submit it within the time frames specified in  item 8 above. By indicating
                   that I have chosen this option, I certify that I will comply with all the
                   requirements pertaining to the conditions for submittal of this study as
                   outlined in the Data Call-in Notice and that I will provide the protocols
                   and progress reports required in item 5 above.

      Option 2.    ON BOTH FORMS:  (Agreement to Cost Share) I have entered into an
                   agreement with one or more registrants to develop data jointly. By
                   indicating that I have chosen this option,  I certify that I will comply with
                   all the requirements pertaining to sharing in the cost of developing data
                   as outlined in the Data Call-in Notice.
                                       172

-------
                    However, for Product Specific Data, I understand that this
             option is available for acute toxicity or certain efficacy data ONLY if
             the Agency indicates in an attachment to this notice that my product is
             similar enough to another product to qualify for this option. I certify that
             another party in the agreement is committing to submit or provide the
             required data; if the required study is not submitted on time, my product
             may be subject to suspension.

Option 3.     ON BOTH FORMS:  (Offer to Cost Share) I have made an offer to
             enter into an agreement with one or more registrants to develop data
             jointly.  I am also submitting a completed "Certification of offer to Cost
             Share in the Development of Data" form. I am submitting evidence that
             I have made an offer to another registrant (who has an obligation to
             submit data) to share in the cost of that data. I am including a copy of
             my offer and proof of the other registrant's receipt of that offer.  I am
             identifying the party which is committing to submit or provide the
             required data; if the required study is not submitted on time, my product
             may be subject to suspension. I understand that other terms under Option
             3 in the Data Call-in TSTotice apply as well.

                    However, for Product Specific Data,,  I understand that this
             option is available only for acute toxicity or certain efficacy data and
             only if the Agency indicates in an attachment to this Data Call-in Notice
             that my product is similar enough to another product to qualify for this
             option.                 ,

Option 4.     ON BOTH FORMS:  (Submitting Existing Data)  I will submit, an
             existing study by the specified due date that has never before been
             submitted to EPA. By indicating that I have chosen this option, I certify
             that this study meets all the requirements pertaining to the conditions for
             submittal of existing data outlined in the Data Call-in Notice and I have
             attached the needed supporting information along with this response.

Options.     ON BOTH FORMS:  (Upgrading a Study)  I will submit by the
             specified due date, or will cite data to upgrade a study that EPA has
             classified as partially acceptable and potentially upgradeable. By
             indicating that I have chosen this option, I certify that I have met all ,the
             requirements pertaining to the conditions for submitting or citing
             existing data to upgrade a study described in the Data  Call-In Notice. I
             am indicating on attached correspondence the Master Record
             Identification Number (MRID) that EPA has assigned to the data  that I
             am citing as well as the MRID of the study I am attempting to upgrade.

Option 6.     ON BOTH FORMS:  (Citing a Study)  I am citing an existing  study
             that has been previously classified'by EPA as acceptable,  core,  core
                                  173

-------
             minimum, or a study that has not yet been reviewed by the Agency. If
             reviewed, I am providing the Agency's classification of the study.

                   However, for Product Specific Data, I am citing another
             registrant's study.  I understand mat this option is available ONLY for
             acute toxicity or certain efficacy data and ONLY if the cited study was
             conducted on my product, an identical product or a product which the
             Agency has "grouped"  with one or more other products for purposes of
             depending on the same  data. I may also choose this option if I am citing
             my own data. In either  case, I will provide the MRID or Accession
             number (s).  If I cite another registrant's data, I will submit a completed
             "Certification With Respect To Data Compensation Requirements"
             form.

FOR THE GENERIC DATA FORM ONLY;  The following three options
(Numbers 7, 8, and 9) are responses that apply only to the "Requirements Status
and Registrant's Response Form" for generic data.

Option 7.     (Deleting Uses)  I am attaching an application for amendment to my
             registration deleting the uses for which the data are required.

Option 8.     (Low Volume/Minor Use Waiver Request) I have read the statements
             concerning low volume-minor use data waivers in the Data Call-in
             Notice and I request a low-volume minor use waiver of the data
             requirement. I am attaching a detailed justification to support this waiver
             request including, among other things, all information required to
             support the request. I understand that, unless modified by the Agency in
             writing, the data requirement as stated in the Notice governs.

Option 9.     (Request for Waiver of Data) I have read the statements concerning data
             waivers other than lowvolume minor-use data waivers in the Data
             Call-in Notice and I request a waiver of the data requirement. I am
             attaching a rationale explaining why I bek'eve the data requirements do
             not apply. I am also submitting a copy of my current labels. (You must
             also submit a copy of your Confidential Statement of Formula if not
             already on file with EPA). I understand that, unless modified by the
            ' Agency in writing, the  data requirement as stated in the Notice governs.

FOR PRODUCT SPECIFIC DATA; The following option (number 7) is a
response that applies to the "Requirements Status and Registrant's Response
Form" for product specific data.

Option 7.     (Waiver Request) I request a waiver for this study because it is
             inappropriate for my product. I am attaching a complete justification for
             this request, including technical reasons, data and references to relevant
                                  174

-------
 Item 10.



 Item 11.

.Item 12.
       EPA regulations,, guidelines or policies. [Note: any supplemental data
       must be submitted in the format required by P.R. Notice 86-5]. I
       understand that this is my only opportunity to state the reasons or   -
       provide information in support of my request. If the Agency approves
       my waiver request, I will not be required to supply the data pursuant to
       Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver request,
       I must choose a method of meeting the data requirements of this Notice
       by the due date stated by this Notice. In this case, I must, within 30
       days-of my receipt of the Agency's written decision, submit a revised
       "Requirements Status" form specifying the option chosen. I also
       understand that the deadline for submission of data as specified by the
       original Data Call-in notice will not change.

ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date all other pages of this form.

ON BOTH FORMS: Enter the date of signature.

ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response."
 Item 13.      ON BOTH FORMS: Enter the phone number of your company contact.
    NOTE:   You may provide additional information that docs not fit on this form in a signed letter that accompanies this your response. For example, you
           may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
                                           175

-------

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EPA'S BATCHING OF NORFLURAZON PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGKTRATION

      In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing norfiurazon as the
active ingredient, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), type of
formulation (e.g., emulsifiabie concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially similar" since some products
within a batch may not be considered chemically similar or have identical use patterns.

      Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need
arise.

      Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrant's option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by  today's standards (see
acceptance criteria attached), the formulation tested is considered by EPA to be similar for ,
acute toxicity, and the formulation has not been significantly altered  since submission and
acceptance of the acute toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product,  the
registrant must indicate the formulation actually tested by identifying the corresponding GSF.

      In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the
Agency within 90 days of receipt. The  first form, "Data Call-in Response," asks whether the
registrant will meet the data requirements for each product. The second form, "Requirements
Status and Registrant's Response," lists the product specific data required for each product,
including the standard six acute toxicity tests.  A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on someone else to do so.
If a registrant supplies the data to support a batch of products, he/she must select one of the
following options: Developing Data (Option 1), Submitting an  Existing Study (Option 4),
Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant
depends on another's data, he/she must choose among: Cost Sharing (Option  2),  Offers to
                                          176

-------
 Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
 participate in a batch, the choices are Options 1,  4, 5 or 6. However, a registrant should
 know that choosing not to participate in a batch does not preclude other registrants in the batch
 from citing his/her studies and offering to cost share (Option 3) those studies.

       Eight products were found which contain norflurazon as an active ingredient. The
 products have been divided into two batches.  One batch consists solely of the technical
 product, EPA Registration No.  55947-55. As there is currently no acceptable inhalation
 LD50 or dermal sensitization test for norflurazon, these tests must be conducted on this
 product.  The other batch consists of all other currently registered norflurazon products.
 There are acceptable data on EPA Registration No. 55947-154. The toxicity profile for this
 product is as follows:                                                ,
Acute oral
Acute dermal
Acute inhalation
Eye irritation
Skin irritation
Dermal sensitization
Category m
Category HI
Category HI
Category IV
Category IV
Non-sensitizer
       None of the other products in this batch are expected to be more toxic than this
product. Therefore, labeling associated with this toxicity profile is acceptable for all of these
products.  Should the registrant wish to lower the toxicity category to IV for acute oral,
dermal, or inhalation toxicity, the appropriate tests are required on the end-use product.

Table 1 (Batch 1)
         EPA Reg.  No.
         % Active Ineredient
           55947-55
               97.8
                                                                        Solid
 Table 2 (Batch 2)
EPA Reg. No.
55947-57
55947-77
55947-78
55947-154
GA95000100
OR90002400
, WA90003200
% Active Ingredient
05.0
78.6
78.6
52.7 norflurazon
26.66 diuron
78.6
78.6
78.6
Formulation Type
. - '' Solid
Solid
Solid
Solid
Solid
Solid
Solid
                                          177,

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Instructions for Completing the Confidential Statement of Formula

The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible,
signed copies of the form are required. Following are basic instructions:
      a.

      b.

      c.


      d.


      e.


      f.

      g-


      h.
      k.

      1.


      m.



      n.
 All the blocks on the form must be filled in and answered completely

 If any block is not applicable, mark it N/A.

 The CSF must be signed, dated and the telephone number of the responsible
 party must be provided.

 All applicable information which is on the product specific data submission
 must also be reported on the CSF.

 All weights reported under item 7 must be in pounds per gallon for liquids and
 pounds per cubic feet for solids.

 Flashpoint must be in degrees Fahrenheit and flame extension in inches.

 For all active ingredients, the EPA Registration Numbers for the currently
 registered source products must be reported under column 12.

 The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and
 all common names for the trade names must be reported.

 For the active ingredients, the percent purity of the source products must be
 reported under column 10 and must be exactly the same as on the source
 product's label.

 All the weights in columns 13.a. and l3.b. must be in pounds, kilograms, or
 grams. In no case will volumes be accepted. Do not mix English and metric
 system units (i.e., pounds and kilograms).

 All the items under column 13.b. must total 100 percent.

 All items under columns 14.a. and 14.b. for the active ingredients must
 represent pure active form.        -

 The upper and lower certified limits for ail  active and inert ingredients must
 follow the 40 CFR 158.175 instructions. An explanation must be provided if
the proposed limits are different than standard certified limits.

When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
                                      179

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    c/EPA
United  States  Environmental  Protection  Agency
            Washington,  DC  20460
   CERTIFICATION OF OFFER TO  COST
SHARE IN THE  DEVELOPMENT OF  DATA
Form Approved

OMB No.  2070-01 OB
         2070-0057
Approval  Expire* 3-31-%
 Public reporting burden for this collection of information is estimated to average 15 minutes per response including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information.  Send comments regarding the burden estimate, or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.WX Washington, DC 20460: and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington. DC 20503.

 Please fill in blanks below.
  Company Name
                                                                           Company Number
  Product Name
                                                                           EPA Reg. No.
 I Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodenticlde Act (FIFRA), if necessary. However, my company would prefer to
 enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
 data                -    -                         -'..."        '          :

 My firm has offered in writing to enter into such an agreement.  That offer was irrevocable and included an
 offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on  all
 terms could not be reached otherwise. This offer was made to the following firm(s) on the following
 date(s):
  Name of Flrm(s)
                                                                            Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
 Signature of Company's Authorized  Representative
                                                 Date
 Nama and Tltla (Please Type or Print)
 EPA Form 8570-32 (5/91)   Replaces EPA Form 8580, which is obsolete

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                       United States Environmental Protection Agency
                                   Washington, DC 20460
                             CERTIFICATION WITH RESPECT TO
                          DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information.  Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief.lnformation Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget,  Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
»
I Certify that:

1.   For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.                                 ,                            ;

2.   That for each study cited in support of registration or reregistratioh under FIFRA that is NOT an exclusive use study, I am the
original data submitter,  or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted-data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(°)(1 )(F) and 3{c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation '
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)

 [ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants'Response Form,"

3.   That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies  I have cited in support of registration or
reregistration under FIFRA.                                                •          .    •• •  •
Signature • >
Date
Name and Title (Please Type or Print)
 iENERAL OFFER TO PAY:  I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature '
Date
Name and Title (Please Type or Print)
 rOrm oo/O-di

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      APPENDIX E - LIST OF AVAILABLE RELATED DOCUMENTS


    The following is a list of available documents for norfiurazon that my further assist you in
responding to this Reregistration Eligibility Decision document.  These documents may be
obtained by the following methods:
           '    -  .   .        '      '                    '
Electronic       .
File format:   Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
             reader. Electronic copies can be downloaded from the Pesticide Special
         .„ • Review and Reregistration Information System at 703-308-7224. They also are
             available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
             using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
             WWW.EPA.GOV., or contact Veronica Dutch at (703)-308.8585.

    1.       PR Notice 86-5.
                                              #           * -     •
    2.       PR Notice 91-2 (pertains to the Label Ingredient Statement).

    3.       A full copy of this RED document.

    4.       A copy of the fact sheet for norfiurazon.


    The following  documents are part of the Administrative Record for norflurazon and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed
on the Chemical Status Sheet.

    1.       Health and Environmental Effects Science Chapters.                    •

:    2.       Detailed Label. Usage Information System (LUIS)  Report.

    The following  Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.

    1.       The Label Review Manual.

    2.       EPA Acceptance Criteria
                                        187

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